Back to what changed for Glaucoma

Reported trial results for Glaucoma

Every Glaucoma trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

81 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

  • NCT02928289 · results posted 24 September 2025

    According to the results reported on ClinicalTrials.gov, this trial compared two procedures used in glaucoma management: a surgical procedure called VISCO360 ab interno canaloplasty, and a laser procedure called Selective Laser Trabeculoplasty (SLT). The trial set out to measure changes in eye pressure (measured in millimetres of mercury, or mm Hg — a standard unit for pressure) over 12 months. A total of 17 people started the trial — 7 in the surgery group and 10 in the laser group. The reported data shows that none of the participants were recorded as having formally completed the trial, which may affect how the results should be interpreted. The main thing the trial measured was the average change in daytime eye pressure from the start of the trial to 12 months, after participants had stopped using any glaucoma eye drops. The reported data shows that the surgery group had an average reduction in eye pressure of 5.2 mm Hg, while the laser group had an average reduction of 3.6 mm Hg. For the secondary measure — looking at how many people achieved at least a 20% drop in eye pressure — the reported data shows that 2 out of 7 participants in the surgery group and 1 out of 10 participants in the laser group reached that level of reduction. It is worth noting that this was a very small trial, with fewer than 10 people in one group and 10 in the other, and no participants were marked as having fully completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02390284 · results posted 26 August 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02390284) was set up to look at three groups of people: those with an abnormal eye signal test result who were untreated, those with an abnormal eye signal test result who received treatment, and those with a normal eye signal test result. The trial was measuring the health of the nerve fibres at the back of the eye (the retina), along with electrical signals produced by the retina in response to visual patterns. A total of 28 participants were enrolled in the "Normal" group, of whom 19 completed the study and 9 did not. Notably, the data shows that no participants were recorded as starting or completing the study in either of the two "Abnormal" groups — results for those groups were not reported in the submitted data. The reported data shows the following figures, all coming from the "Normal" group only. The thickness of the nerve fibre layer at the back of the eye, measured using a scanning technology called Optical Coherence Tomography, was reported as 79 micrometres (a unit of length about one-thousandth of a millimetre). Two measures of the retina's electrical response to visual patterns were also reported: the strength (amplitude) of that signal was 706 nanovolts (a very small unit of electrical voltage), and the timing (phase) of the signal was 67.34 degrees (a way of describing when in a cycle the signal peaks). No outcome figures were reported for the untreated or treated abnormal groups. Because outcome data appears to have been submitted only for the Normal comparison group, and not for the groups the trial was primarily designed to compare, the reported results are quite limited. If you are interested in the full picture of this study, the data as submitted to ClinicalTrials.gov does not provide numbers for the other two participant groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04445519 · results posted 30 May 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04445519) enrolled 691 participants across three groups: 30 people received a lower-dose eye drop called NCX 470 at 0.065% concentration, 328 received a higher-dose NCX 470 at 0.1% concentration, and 333 received a comparison eye drop called latanoprost 0.005% (an already-available glaucoma drop). The trial was measuring changes in eye pressure — formally called intraocular pressure, or IOP — which is the fluid pressure inside the eye. After an early check at two weeks, the lower-dose NCX 470 group was discontinued as planned, and the rest of the trial focused on comparing the higher-dose NCX 470 against latanoprost. The reported data shows that the primary thing being tracked was how much eye pressure dropped from each participant's starting level, measured in millimetres of mercury (mmHg — a standard unit for pressure). For the higher-dose NCX 470 group, the reported average pressure reductions at the 8am and 4pm measurement points ranged from approximately 8.0 to 9.7 mmHg across the three check-in times (two weeks, six weeks, and three months). For the latanoprost group, the reported reductions ranged from approximately 7.1 to 9.4 mmHg across the same time points. A secondary measure of average daily eye pressure reduction told a similar story: the NCX 470 0.1% group showed reported reductions of around 8.8 to 9.0 mmHg, while the latanoprost group showed reductions of around 8.1 to 8.4 mmHg at the same check-ins. The reported data also shows that the number of participants who experienced treatment-emergent adverse events (that is, any new health issue that appeared after starting the treatment) was 13 out of 30 in the lower-dose NCX 470 group, 113 out of 328 in the higher-dose NCX 470 group, and 58 out of 333 in the latanoprost group. The number of participants who did not complete the trial was 3, 14, and 17 in each respective group. The trial did not report a breakdown of what those adverse events specifically were beyond these numbers in the structured results data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03560609 · results posted 29 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03560609) enrolled two groups of participants: people with a condition called keratoconus (a shape change in the cornea, the clear front of the eye) and people with glaucoma (a condition involving pressure-related damage to the eye). In total, only 3 people were recorded as having started the trial — all in the keratoconus group — and no participants were recorded as having joined the glaucoma group. None of the participants were recorded as having completed the trial. The trial was designed to measure changes in eye tissue — specifically in two areas at the back of the eye called the optic nerve head (ONH) region and the peripapillary region (the area surrounding the optic nerve) — when eye pressure was deliberately raised. The specific things being measured included whether tissue deformation (physical change in shape) could be detected, as well as changes in "rim area" (a structural feature around the optic nerve) and "cup depth" (how deep a natural hollow in the optic nerve is), all captured using a scanning technology called OCT (a type of detailed eye imaging). The reported data shows that no numerical results were submitted for any of these outcome measures — the measurements fields are empty for both groups. The reported data shows, in summary, that the trial appears to have stopped very early with only 3 participants starting and none completing it, and no outcome measurement data was reported to ClinicalTrials.gov for any of the planned measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04360174 · results posted 1 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04360174) enrolled 19 people in total, split across four groups (called cohorts) of roughly four to five people each. All 19 participants completed the study — none dropped out. The trial was looking at two main things: any eye-related unwanted events that occurred during treatment, and changes in eye pressure (a measure called intraocular pressure, or IOP — essentially how much fluid pressure is inside the eye) after 12 weeks compared to the start of the study. The reported data shows that the number of eye-related unwanted events recorded during the study were 9 in Cohort 1, 7 in Cohort 2, 9 in Cohort 3, and 1 in Cohort 4. Regarding eye pressure, the reported data shows the average change from the starting measurement at the 12-week mark was −5.6 mmHg (millimetres of mercury, a standard unit for pressure) in Cohort 1, −7.0 mmHg in Cohort 2, −3.0 mmHg in Cohort 3, and −7.4 mmHg in Cohort 4. A negative number here means eye pressure was lower at 12 weeks than it was at the beginning of the study. No further breakdown of these figures — such as individual results or additional timepoints — was included in the submitted data. It is worth noting that with only four to five people per group, this was a very small trial, which is typical of early-stage research designed to gather initial information rather than draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04468633 · results posted 5 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04468633) enrolled 76 people with glaucoma — 37 received a device called the Baerveldt 350 implant and 39 received a device called the Ahmed ClearPath 350 implant. These are small tubes surgically placed in the eye to help drain fluid and reduce pressure. All 39 people in the Ahmed ClearPath group completed the study, while 4 of the 37 in the Baerveldt group did not. The trial was primarily measuring the pressure inside the eye (called intraocular pressure, or IOP) over time, and how many participants experienced a complication. The reported data shows that before the procedures, average eye pressure was around 21.7 mmHg (millimetres of mercury, the unit used to measure eye pressure) in the Baerveldt group and 22.4 mmHg in the Ahmed ClearPath group. Pressure readings were then recorded at several follow-up points — the reported numbers ranged from approximately 10.7 to 16.5 mmHg for the Baerveldt group, and from approximately 11.5 to 15.6 mmHg for the Ahmed ClearPath group across those time points. Regarding complications, the reported data shows that 13 participants in the Baerveldt group and 4 participants in the Ahmed ClearPath group experienced a complication during the study period. The reported data also includes a number of secondary (additional) measurements. The number of eye-drop medications participants were using started at an average of 2.7 in both groups and was reported at lower levels at all later time points across both groups. Vision sharpness, peripheral (side) vision, and corneal (front of the eye) thickness were also measured at various points, with figures reported for both groups — however, the data as submitted does not specify which time points each individual measurement corresponds to for these secondary outcomes, so a full time-by-time comparison cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03861169 · results posted 14 August 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 209 people who had the OMNI® Surgical System procedure, a device used in eye surgery aimed at lowering pressure inside the eye (known as intraocular pressure, or IOP — high IOP is associated with glaucoma). The trial tracked participants over 12 months, measuring two main things: how much their eye pressure changed when they were not taking any eye-pressure-lowering medications, and how many of those medications they were using before versus after the procedure. Of the 209 people who started, 149 completed the trial, and 60 did not complete it. The reported data shows that, among the group analysed according to the study's pre-set rules (called the "per protocol population"), average eye pressure fell by about 8 mmHg (millimetres of mercury — the unit used to measure eye pressure) from the starting point to the 12-month mark, without the use of eye-pressure medications. On average, participants were also using about 1.4 fewer eye-pressure-lowering medications at 12 months compared to when they entered the study. For the secondary outcomes, the reported data shows that 84.2% of eyes in the per-protocol group had their unmedicated eye pressure drop by 20% or more at 12 months; in a broader group of participants (called the mITT group), that figure was 75.9%. Additionally, 77.5% of eyes in the per-protocol group had their unmedicated eye pressure recorded between 6 and 18 mmHg at 12 months, compared with 70.9% in the mITT group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05674890 · results posted 9 August 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT05674890) compared two types of visual field tests — a standard clinic-based machine called the Humphrey Field Analyser (HFA) and a newer virtual reality headset system (SSVR). A total of 98 people started the trial (40 in one group, 58 in the other), and 81 completed it. The trial measured how similar the results from the two devices were, by looking at three technical readings from each test: "mean deviation" (how much a person's overall vision differs from what's typical for their age), "pattern standard deviation" (how uneven or patchy any vision loss is), and how long the test took to complete. The reported data shows the following numbers for the two devices side by side. For mean deviation, the readings were −7.17 decibels (a unit of light sensitivity) for one device and −6.88 decibels for the other. For pattern standard deviation, the figures were 4.26 decibels and 6.38 decibels respectively. Test duration was reported as approximately 323 seconds (about 5.4 minutes) for one device and 372 seconds (about 6.2 minutes) for the other. The trial also asked participants about their experience using each device. For comfort, the reported data shows that for the HFA, 0 rated it very uncomfortable, 3 uncomfortable, 7 neutral, 27 comfortable, and 15 very comfortable; for the VR headset, 2 rated it very uncomfortable, 22 uncomfortable, 17 neutral, 7 comfortable, and 4 very comfortable. Similar response breakdowns were reported for how easy the instructions were to understand and how easy the test was to perform, with the data not reported in a way that clearly labels which set of numbers belongs to which device beyond the order presented. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02507687 · results posted 10 May 2024

    According to the results reported on ClinicalTrials.gov, this trial compared two approaches to lowering eye pressure in people with glaucoma or raised eye pressure. One approach used a procedure called selective laser trabeculoplasty (SLT — a type of laser treatment applied to the eye's drainage area), and the other used a small implant called Bimatoprost SR 10 µg, which slowly releases a pressure-lowering medicine inside the eye. The trial was run in two stages; the main reported results come from Stage 2, which enrolled 183 participants (92 in one group, 91 in the other). Each participant had one eye treated with SLT and the other with the implant, so both treatments were compared within the same person. Around 155 of those participants completed the study. The reported data shows that the main thing being measured was the change in eye pressure (measured in millimetres of mercury, or mmHg — a standard unit for pressure) from the start of the trial to several points in time. At 4 weeks, eye pressure had fallen by an average of 6.2 mmHg in the SLT-treated eyes and 6.8 mmHg in the implant-treated eyes. At 12 weeks those figures were 6.4 mmHg and 6.9 mmHg, and at 24 weeks they were 6.5 mmHg and 6.9 mmHg respectively — in all cases a negative number means pressure went down from the starting point. For a secondary measure looking at how many eyes reached at least a 20% drop in pressure from baseline regardless of treatment cycle, the reported data shows figures ranging roughly from 59% to 87% across various time points for the two groups. The reported data also shows a secondary measure of how long it took before participants needed additional eye pressure–lowering treatment outside the study. The median time (the midpoint — meaning half of participants reached this point sooner and half later) was reported as 263 days for SLT-treated eyes and 276 days for the implant-treated eyes, though some values for this measure were noted as not available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04629521 · results posted 26 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04629521) enrolled 54 participants who had undergone cataract surgery combined with insertion of a small eye device called the CyPass micro-stent. Of those, 46 completed the study and 8 did not. The trial was a long-term follow-up study that tracked participants for up to nine years after their original surgery. It measured two main things: whether participants experienced any eye-related adverse events (unexpected medical problems affecting the eye), including any that could threaten sight; and the health of a layer of cells at the front of the eye called the corneal endothelium — cells that help keep vision clear, and which cannot regrow if lost. The reported data shows that at one time point, 18.5% of eyes had a sight-threatening adverse event recorded, while at the remaining five time points that figure was 0.0%. For other (non-sight-threatening) eye adverse events, the reported percentages across multiple time points ranged from 1.9% up to 38.9%. Regarding the corneal cell counts, the reported average (mean) number of these cells per square millimetre was approximately 1,802 at the earliest follow-up time point reported, falling to around 1,669 and then to approximately 1,575 at later time points. To put those numbers in context, the trial's own description notes that a typical healthy adult count is around 2,500 to 3,000 cells per square millimetre. The spread of individual results at years 8 and 9 was wide — the reported data shows some participants had counts as low as the high hundreds, while others remained above 2,400. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04200651 · results posted 31 January 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04200651) enrolled 24 participants in total — 14 in the DEXTENZA® group (a slow-release steroid insert placed in the eye) and 10 in the Prednisolone Acetate 1% eye drop group. Of those, 11 and 5 participants respectively completed the study. The trial was measuring changes in eye pressure and vision sharpness after eye surgery, as well as tracking unwanted events, changes in glaucoma medications, and signs of swelling at the back of the eye (a condition called cystoid macular oedema). The reported data shows the following numbers. For eye pressure (measured in mmHg, the standard unit for pressure in the eye), both groups showed a reduction from their starting levels: at one month, the DEXTENZA® group dropped by about 2.9 mmHg and the eye drop group by about 6.6 mmHg; at three months, the drops were roughly 2.1 and 4.6 mmHg respectively. For vision sharpness (measured on a scale called logMAR, where a lower number means sharper vision), both groups also showed reductions from their starting levels at one and three months. Regarding unwanted events, 3 eyes in the DEXTENZA® group and 0 eyes in the eye drop group were recorded as having adverse events. Changes in the number of glaucoma medications used were small and similar across both groups. Among secondary outcomes, 25% of eyes in the DEXTENZA® group required additional steroid eye drops during the study. No cases of swelling at the back of the eye were recorded in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05022004 · results posted 18 January 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 597 people in total — 297 in the BRIN-20-01 group and 300 in the Azopt® group. The vast majority completed the study (287 and 289 respectively). The trial was measuring eye pressure (called intraocular pressure, or IOP — the fluid pressure inside the eye) in both eyes, comparing the two treatments at several points in time. Azopt® is an already-approved eye-pressure medicine, and BRIN-20-01 appears to be a version being compared against it. The reported data shows that at the start of the study, average eye pressure in both groups was similar — around 24.5 to 25.1 mmHg (millimetres of mercury, the unit used to measure eye pressure). Across the various time points measured, the BRIN-20-01 group recorded average eye pressures roughly in the range of 19.8 to 24.9 mmHg, while the Azopt® group recorded averages roughly in the range of 19.6 to 25.1 mmHg. The reported data also shows changes from those starting values. For the BRIN-20-01 group, the reported changes at different time points ranged from approximately −4.67 to −5.82 mmHg (meaning eye pressure readings were lower than at the start). For the Azopt® group, the reported changes ranged from approximately −5.27 to −6.44 mmHg. The specific time points for each measurement pair were not detailed in the data provided to ClinicalTrials.gov in a way that allows them to be individually labelled here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05790408 · results posted 15 November 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT05790408) enrolled 10 people in a single study group. The trial was looking at a type of eye surgery related to glaucoma — specifically, it was measuring whether a surgical procedure could lower eye pressure (measured without eye-drop medications) by at least 20% compared to each person's pressure before the operation. The trial also looked at whether a special imaging tool used during surgery, called intraoperative OCT (a type of real-time internal scanning), could successfully capture images of the surgical area during the procedure. The reported data shows that of the 10 people who started the trial, 7 completed it and 3 did not finish. For the main goal — reducing eye pressure by at least 20% — the results include two separate measurements reported for the study group: 5 participants met this target at one specified follow-up point, and 2 participants met it at another specified follow-up point. The trial did not provide further detail in the submitted data to clarify which time points these figures relate to. For the imaging goal, the reported data shows that all 7 participants who completed the trial had successful imaging of the surgical area using the intraoperative scanning tool. A third planned measure — looking at pre-operative scans to see if they could predict surgical outcomes — had no results data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04615403 · results posted 26 September 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04615403) enrolled 33 participants, all of whom were in a single group that underwent a lens implantation and/or exchange procedure. The trial was primarily measuring ocular (eye-related) safety — specifically, how many participants experienced any unwanted medical events in the eye being treated, both during and after the procedure. Thirty-two of the 33 participants completed the study, with one person not completing it (the reason was not reported in the data provided). The reported data shows that the main outcome being tracked was the number of participants who experienced what are called adverse events — these are any unintended or unwanted occurrences that happen during or after a medical procedure. According to the results reported on ClinicalTrials.gov, 13 out of 33 participants experienced at least one such event in the study eye. No further breakdown of what those events were, how serious they were, or how they resolved was included in the structured data provided. It is worth noting that the data submitted covers only this one primary outcome measure, and no secondary outcome measure results were included in the structured data — so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04949802 · results posted 21 September 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants in a single group who received a laser treatment. The trial was measuring changes in eye pressure (known as intraocular pressure, or IOP — the pressure inside the eye) after the laser procedure. Of the 15 people who started, 12 completed the study and 3 did not finish. The reported data shows that, at the end of the study, the average eye pressure across participants was 12.7 mmHg (millimetres of mercury — the unit used to measure eye pressure). On average, this represented a reduction of 38.5% compared to where participants' eye pressure had been at the start of the trial. For the secondary outcome, the reported data shows that 18 eyes achieved a reduction in eye pressure of at least 20% from their starting level. It is worth noting that the number of eyes (18) is higher than the number of participants (15), which likely reflects that some participants had both eyes included in the measurement, though this detail was not explicitly explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03519386 · results posted 14 September 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03519386) enrolled 590 participants across three groups — Implant Group 1 (200 people), Implant Group 2 (197 people), and a Control Group (193 people). The trial was measuring eye pressure, known as intraocular pressure (IOP), which is the pressure inside the eye measured in millimetres of mercury (mmHg). Specifically, it tracked how much eye pressure changed from each participant's starting level at several points in time — Day 10, Week 6, and Month 3 — with measurements taken at 8am and 10am. The reported data shows that across all three groups, eye pressure was lower at each follow-up point compared to where it started. At Day 10, the average change from baseline was around −8.40 mmHg for Implant Group 1, −8.48 mmHg for Implant Group 2, and −7.69 mmHg for the Control Group (8am readings), with similar figures at 10am. By Month 3, the reported average changes were approximately −7.34 mmHg, −7.26 mmHg, and −7.09 mmHg respectively at 8am, and −7.59 mmHg, −7.62 mmHg, and −6.85 mmHg at 10am. These numbers represent the average difference from each person's own starting eye pressure — a negative number means pressure was lower than at the start. For the secondary outcome — comparing average eye pressure between the implant groups and the control group out to 12 months — the data was not reported in the ClinicalTrials.gov submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03697811 · results posted 30 August 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people who had not been responding well — or were not responding at all — to a common eye-pressure-lowering drop called latanoprost. All participants were given a different eye drop, DE-117 ophthalmic solution 0.002%, and the trial tracked what happened to the pressure inside their eyes (called intraocular pressure, or IOP — a measure of the fluid pressure within the eye) over three months. By the end of the study, 104 people completed the trial and 3 did not. The reported data shows that the main thing being measured was the average daytime eye pressure, taken at three set times each day (8am, 12pm and 4pm). At the three-month mark, the reported average change in this daytime eye pressure from the starting point was a reduction of 2.96 mmHg (millimetres of mercury, the unit used to measure eye pressure). The reported data also shows that at the earlier check-in points — week 2 and week 6 — the average reductions were 2.87 mmHg and 2.89 mmHg respectively. In percentage terms, the reported reductions in average daytime eye pressure were approximately 12.2% at week 2, 12.4% at week 6, and 12.6% at month 3. When broken down by individual time-of-day measurements, the reported reductions at each check-in point ranged from roughly 2.4 mmHg to 3.4 mmHg depending on the time of day. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04318132 · results posted 24 August 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people across four groups: 45 people with normal eyes, 47 with retinal conditions, 46 with glaucoma, and 32 with corneal disease. The study was comparing a piece of eye-imaging equipment called the NIDEK Mirante against two already-approved devices — the Optovue RTVue XR Avanti (which uses a scanning technology called OCT to measure layers inside the eye) and the OPTOS P200DTx (which captures wide-field photographs of the back of the eye). The goal was to see how closely the measurements and image quality from the NIDEK Mirante matched those from the established devices. Almost all participants completed the study; three people in the glaucoma group did not finish. The reported data shows the following measurement comparisons. For the thickness of the central part of the retina (the macula), the average difference between the two devices ranged from roughly 10.7 to 11.4 micrometres (a micrometre is one-thousandth of a millimetre) across the three groups measured. For the thickness of the nerve fibre layer around the optic nerve — relevant to glaucoma — reported differences were between approximately 7.5 and 9.2 micrometres depending on the group. For corneal (front-of-eye) thickness, the reported average differences were about 16.5 micrometres in the normal group and 14.8 micrometres in the corneal disease group. Image quality was rated on a 0–3 scale (where 3 is the best); scores for the wide-field camera images ranged from 2.2 to 3.0 across groups and image types, and scores for the angle-of-the-eye images ranged from 2.1 to 2.4. The reported data also shows a repeatability measure (how consistently the device gives the same reading on repeat scans), expressed as a percentage — values across all three groups were all below 1.2%, meaning the device produced very similar readings when the same eye was scanned more than once. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01956942 · results posted 13 June 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people with open-angle glaucoma — 38 received a treatment called Micropulse Laser Trabeculoplasty (MLT) and 31 received Selective Laser Trabeculoplasty (SLT). All 69 participants completed the study. The trial was measuring eye pressure (the fluid pressure inside the eye, known as intraocular pressure or IOP), specifically looking at how much each laser procedure changed that pressure compared to where it started. The reported data shows that, on average, eye pressure in the MLT group fell by about 17% from its starting level, compared to about 14% in the SLT group. When measured in the actual pressure units used by eye specialists (millimetres of mercury, or mmHg), the average pressure reading was around 15.7 in the MLT group and 14.35 in the SLT group after treatment. A separate reported measure looked at how many participants had a pressure drop of at least 3 mmHg — the reported figures were 37% of people in the MLT group and 36% in the SLT group. For the secondary outcome, pain was rated by participants on a scale from 0 (no pain) to 10 (severe pain). The reported data shows pain scores for the MLT group of 1.34 and 0.89 across two time points, compared to 2.83 and 2.81 for the SLT group, though the specific time points for each measurement were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04285580 · results posted 8 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04285580) enrolled 37 people in total — 31 received a treatment called Bimatoprost SR 10 μg (a slow-release implant placed in the eye) and 6 received eye drops called LUMIGAN 0.01% (bimatoprost 0.01%). The trial was primarily measuring changes in eye pressure (the fluid pressure inside the eye, known as intraocular pressure or IOP) over time, as well as tracking how many participants experienced any unwanted medical events during the study. The reported data shows that eye pressure went down from the starting point in both groups across all measurement time points. For the implant group, the reported reductions in eye pressure ranged from about 1.8 to 3.7 mmHg (millimetres of mercury, the unit used to measure eye pressure) below the starting level. For the eye drops group, the reductions ranged from about 3.2 to 5.0 mmHg below the starting level. Regarding unwanted medical events, the reported data shows that 12 out of 31 participants in the implant group and 4 out of 6 participants in the eye drops group experienced at least one such event during the study. For the secondary outcome — how much eye pressure fluctuated over time — the implant group showed a reported average reduction in the range of fluctuation of 1.6 mmHg, while the eye drops group showed a small reported increase in fluctuation of 0.7 mmHg. It is worth noting that the two groups were quite different in size (31 versus 6 participants), which the reported data does not explain further. Any figures not listed above were not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03362931 · results posted 17 May 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people who had been diagnosed with glaucoma and were treated with a small implanted device called the XEN45 Glaucoma Treatment System. The trial had one group only — everyone received the XEN45 device. The main thing researchers were measuring was how many participants had their eye pressure (a key measure in glaucoma) drop by at least 20% from their starting level after 12 months, while using the same number of eye-pressure-lowering medications or fewer. Of the 62 people who started, 59 completed the trial, and 3 did not complete it (the reasons were not detailed in the reported data). The reported data shows that 80.5% of participants met that eye pressure reduction target at the 12-month mark while on the same or fewer medications. In plain terms, roughly four out of every five people in the trial had their eye pressure fall by at least one-fifth compared to where it started. As a secondary measure — something tracked alongside the main goal — researchers also looked at whether participants were using more or fewer eye-pressure-lowering medications after receiving the device. The reported data shows an average change of −1.6 medications per person, meaning participants were, on average, using about one to two fewer medications than before the procedure. It is important to note that this trial had only one group and no comparison group (such as people who received a different treatment or no treatment), so the numbers describe what was observed in this particular group of patients only. The reported figures reflect what was measured and recorded — they do not on their own tell us why those changes occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04024072 · results posted 6 March 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 495 participants in total — 249 in the "Perrigo Active" group and 246 in the "Reference Active" group. The trial was comparing two versions of an eye drop, measuring changes in eye pressure (called intra-ocular pressure, which is simply the fluid pressure inside the eye) over six weeks. Most participants completed the study: 247 from the Perrigo group and 237 from the Reference group. The reported data shows that the main thing being measured was the average change in eye pressure at four specific time points — at around 8:00 a.m. and 10:00 a.m. on both Week 2 and Week 6. For the Perrigo group, the reported average pressure changes at those four time points were −4.25, −4.22, −4.43, and −4.05 mmHg (millimetres of mercury, a standard unit for measuring pressure). For the Reference group, the corresponding figures were −3.80, −4.00, −4.20, and −4.06 mmHg. A negative number here simply means pressure was lower at that point compared to where it started. The reported data shows that both groups had broadly similar changes in eye pressure across the four measurement points, though no further statistical detail (such as whether any difference between the groups was considered meaningful) was included in the submitted results. No other outcome measures were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04620135 · results posted 27 February 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 245 people in total — 122 in one group and 123 in another. The trial compared two different eye drop medicines used to lower the pressure inside the eye (known as intraocular pressure, or IOP). High eye pressure is considered a risk factor for glaucoma, a condition that can damage the optic nerve. One group used Netarsudil 0.02% eye drops (alongside a vehicle, which is an inactive version of the drops), and the other group used Ripasudil 0.4% eye drops. The main thing being measured was average eye pressure at four weeks, taken at three different times of day and averaged together. The reported data shows that at the four-week mark, the average eye pressure reading in the Netarsudil group was 15.96 mmHg (millimetres of mercury, the standard unit for eye pressure), compared with 17.71 mmHg in the Ripasudil group. Earlier measurements at one and two weeks showed a similar pattern — the Netarsudil group recorded readings of approximately 16.28 mmHg and 16.02 mmHg, while the Ripasudil group recorded approximately 17.87 mmHg and 17.83 mmHg at those same time points. The reported data also shows that both groups started from similar average eye pressure levels (around 20.5 mmHg for the Netarsudil group and 20.8 mmHg for the Ripasudil group). The reported change from that starting point by week four was a reduction of approximately 4.65 mmHg in the Netarsudil group and approximately 2.98 mmHg in the Ripasudil group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04616573 · results posted 1 December 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT04616573) was set up to compare three different surgical approaches for reducing eye pressure in people with glaucoma: a procedure called "ab-interno transluminal viscoelastic delivery with trabeculotomy" using the OMNI Surgical System, a similar but slightly different OMNI procedure without the trabeculotomy step, and implantation of a small device called iStent Inject. The trial planned to measure changes in eye pressure (the force of fluid inside the eye, measured in units called mmHg) without the use of pressure-lowering eye drops, as well as changes in the number of medications participants needed. However, the trial was terminated very early — only one person was enrolled and treated, and that person left the study after just one week of follow-up. The sponsors have noted that no meaningful conclusions can be drawn from this trial. The reported data shows figures only for the one participant, who was in the OMNI-with-trabeculotomy group. The primary outcome — the change in unmedicated daytime eye pressure — was reported as 13.3 mmHg. For the secondary outcomes, the reported data shows that 1 eye met the target of a 20% or greater reduction in eye pressure, 1 eye had a pressure reading falling within the 6–18 mmHg range considered in the study, and the change in the number of pressure-lowering medications was recorded as 1. No data was reported for the other two treatment groups, as no participants were enrolled in them. Because only a single participant completed even one week of follow-up before the trial closed, the reported numbers reflect just that one individual's results and cannot be used to draw any broader conclusions about these procedures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03804684 · results posted 29 June 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 healthy participants and 44 people with glaucoma. Of these, 25 healthy participants and 26 people with glaucoma completed the study. The trial was measuring how well two different vision-testing machines agreed with each other when checking how sensitive the eye is to light across the full field of vision. One machine was the Humphrey Visual Field analyser (a standard clinic device) and the other was the VisuALL (a newer device). Sensitivity to light is recorded in units called decibels — in this context, a higher decibel number means the eye could detect a dimmer light, which represents better vision. The reported data shows that, across several measurements of average light sensitivity, the healthy control group recorded values roughly in the range of 28.6 to 30.3 decibels, while the glaucoma group recorded values roughly in the range of 21.8 to 24.8 decibels. For the primary measure of overall agreement between the two machines across the whole field of vision, the reported data shows a correlation figure of 0.5 for the healthy controls and 0.8 for the glaucoma group. (A correlation is a number between 0 and 1 that describes how closely two sets of measurements match — 1 would mean perfect agreement.) For the secondary measures looking at specific portions of the visual field, the reported agreement figures ranged from 0.3 to 0.4 in healthy controls and 0.6 to 0.8 in the glaucoma group, depending on which region of the visual field was examined. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02805257 · results posted 31 May 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 119 people in total — 60 in the Mitomycin-C group and 59 in the Balanced Salt Solution (BSS) group. Of those, 53 and 52 people respectively completed the study. The trial was measuring eye pressure (the fluid pressure inside the eye) one year after a type of eye surgery, and also tracked eye pressure at six months, the number of eye-drop medications needed, vision scores, and any unintended events that occurred during surgery. The reported data shows that at the one-year mark, the average eye pressure reading was 13.1 mmHg (millimetres of mercury, the standard unit for eye pressure) in the Mitomycin-C group and 16.2 mmHg in the BSS group. At six months, the reported average eye pressure readings were 14.6 mmHg and 16.1 mmHg respectively. For the number of glaucoma eye drops being used — both at six months and at one year — the reported averages were 1.2 drops in the Mitomycin-C group and 1.6 drops in the BSS group. Vision was measured using a letter-reading test scored from 0 to 100 (where 85 represents normal 20/20 vision); at six months, the reported average scores were 12.81 for the Mitomycin-C group and 15.33 for the BSS group. Regarding unintended events during surgery, the reported data shows 3 participants in the Mitomycin-C group and 5 in the BSS group experienced at least one such event; further breakdown figures were also listed, though some category labels were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02636946 · results posted 23 February 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 144 participants in total — 72 in each group. Each participant had one eye treated with a procedure called Selective Laser Trabeculoplasty (SLT), a type of laser treatment, and the other eye treated with a slow-release implant containing a medicine called bimatoprost (Bim SR 15 µg). The trial was measuring eye pressure — specifically the fluid pressure inside the eye, known as intraocular pressure (IOP), measured in millimetres of mercury (mmHg). The main goal was to track how eye pressure changed over time in each eye, with check-ins at weeks 4, 12, and 24. The reported data shows that at the start of the trial, average eye pressure was very similar in both treatment groups — around 24.4–24.5 mmHg. Over the course of the trial, both eyes showed a reduction in eye pressure from their starting levels. At week 4, the laser-treated eyes showed an average reduction of about 6.3 mmHg, while the implant-treated eyes showed an average reduction of about 7.0 mmHg. At week 12, the reported reductions were approximately 6.3 mmHg for laser-treated eyes and 6.8 mmHg for implant-treated eyes. At week 24, the figures were approximately 6.3 mmHg and 6.6 mmHg respectively. The reported data also shows that at some later time points (weeks 15 and 20), the reductions in eye pressure were somewhat smaller in both groups compared to earlier check-ins. The reported data also includes a secondary measure looking at how long it took before participants needed an additional eye-pressure-lowering treatment outside the study. The median time for this was reported as 410 days for the laser-treatment group and 446 days for the implant group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02691455 · results posted 14 October 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people with glaucoma — 23 assigned to receive a second aqueous shunt (a small drainage device implanted in the eye) and 22 assigned to receive transscleral cyclophotocoagulation (a laser-based procedure targeting part of the eye that produces fluid). The trial was comparing these two procedures in people whose glaucoma had not been adequately controlled by a previous shunt. The main thing being measured was how many eyes "failed" treatment, based on eye pressure remaining too high or too low, the need for further glaucoma surgery, the addition of a specific oral medication, or complete loss of light perception. Smaller numbers of participants remained in follow-up over time, and 7 people in the shunt group and 5 in the laser group were recorded as completing the study. The reported data shows that, for the primary outcome of treatment failure, the numbers varied across the different time points reported. At one reported time point, 3 eyes in the second shunt group and 2 eyes in the laser group met the criteria for treatment failure; at two other reported time points, 0 eyes in either group met those criteria. For one of the secondary outcomes — the number of eyes that lost two or more lines of vision on the standard eye chart — the reported data shows 3 eyes in the second shunt group and 8 eyes in the laser group experienced this level of vision loss. For vision-threatening complications, the reported numbers varied across different categories and time points, with small numbers recorded in both groups. The reported data also shows a small average change in vision sharpness at one week compared to the start: 0.16 units in the shunt group and 0.14 units in the laser group (where a higher number indicates a slight decrease in sharpness). It is worth noting that the trial was relatively small, and participant numbers dropped notably over time, which the reported data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03187418 · results posted 8 October 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 participants, all of whom completed the study with no drop-outs. All participants received a procedure called Micropulse Trans-scleral Cyclophotocoagulation (a type of laser treatment applied to the outside of the eye). The trial was measuring eye pressure (known as intraocular pressure, or IOP) as its main focus, along with several other things including how many people needed a repeat treatment, how many eye pressure-lowering medications participants were using, their vision sharpness, and a measure of the optic nerve called the cup-to-disc ratio. The reported data shows that the primary (main) outcome — eye pressure at the end of the study — was recorded at an average of 15.2 mmHg (millimetres of mercury, the unit used to measure eye pressure). For context, the secondary (additional) eye pressure measurements reported at various earlier time points across the study were 18.2, 19.2, 18.6, 17.9, and 16.7 mmHg. The reported data also shows that 10 out of 52 participants needed a repeat laser treatment during the study. The average number of eye pressure-lowering medication classes participants were using was reported at various time points across the study as 3.5, 3.4, 3.4, 3.4, 3.2, and 3.2. Vision sharpness scores (measured on a LogMAR scale, where lower numbers generally indicate sharper vision) were reported at multiple time points as 0.81, 0.84, 0.79, 0.77, 0.79, and 0.82. The cup-to-disc ratio — a measure of the optic nerve's appearance — was reported as 0.82, though baseline comparison data was not separately reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03452033 · results posted 2 August 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 87 people in total, split across four groups. Three groups used different strengths of an eye drop called H-1337 (at concentrations of 0.06%, 0.2%, and 0.6%), while a fourth group used a "vehicle" — a version of the drop without the active ingredient, used as a comparison. The trial was measuring eye pressure (called intraocular pressure, or IOP — the fluid pressure inside the eye) and tracking any unwanted health events that occurred during the study. All 87 participants completed the trial. The reported data shows that after 28 days, the average change in eye pressure from the starting level was measured for each group. Participants using H-1337 0.06% had an average reduction of 4.45 mmHg (millimetres of mercury, the unit used to measure eye pressure); those using H-1337 0.2% had an average reduction of 5.16 mmHg; and those using H-1337 0.6% had an average reduction of 4.93 mmHg. By comparison, the vehicle (no active ingredient) group had an average reduction of just 0.39 mmHg. As a secondary measure, the reported data shows that unwanted health events during the study were recorded in 9 out of 21 participants in the 0.06% group, 9 out of 22 in the 0.2% group, 14 out of 22 in the 0.6% group, and 4 out of 22 in the vehicle group. No further detail about the nature of those events was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00772330 · results posted 14 July 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people with glaucoma who received a small implanted device called the MIDI Arrow. The trial was designed to assess the performance and safety of this device. Of the 23 people who started the trial, 20 completed it and 3 did not. The main thing being measured was whether the device could lower eye pressure (the fluid pressure inside the eye) to below a certain level, or reduce it by at least 20% from where it started before the procedure, without the person needing additional glaucoma surgery. The reported data shows that at the starting point, the average eye pressure across participants was around 23.78 mmHg (millimetres of mercury — a standard unit for measuring eye pressure). According to the results reported on ClinicalTrials.gov, the average eye pressure readings at follow-up visits across the study period ranged from approximately 7.4 to 12 mmHg. For the primary outcome — the number of participants meeting the pressure target without needing further surgery — the reported figures at each follow-up time point ranged between 17 and 23 participants. The reported data also shows the average surgical procedure time was about 25 minutes, and that 17 out of 23 investigators rated the device insertion as the easiest score on a 5-point scale, with 6 giving it the second-easiest rating. Visual field data was noted as not available for summary. Data on visual acuity (sharpness of vision) was recorded at multiple time points but the results varied across visits and no single summary figure was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03808688 · results posted 29 September 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03808688) looked at an eye drop medicine called Netarsudil Ophthalmic Solution 0.02% in people with raised pressure inside the eye — a condition often linked to glaucoma. A total of 260 participants were enrolled: 99 in a group receiving Netarsudil as their only eye pressure medicine (monotherapy), and 161 in a group receiving Netarsudil alongside other eye pressure medicines they were already using (concomitant therapy). Of those who started, 81 and 138 respectively completed the study. The main thing being measured was the percentage change in eye pressure (called intraocular pressure, or IOP — the fluid pressure inside the eye) from the start of the study to 12 weeks later. The reported data shows that within the monotherapy group, results varied depending on what treatment participants had been on before: those who had never been on any eye pressure medicine previously showed an average pressure reduction of about 16.9%; those who had switched from one other medicine showed an average change of −2.3% (a small reduction); and those who had switched from two other medicines showed an average change of +0.2% (essentially no change). The reported data shows that participants in the concomitant therapy group — who kept taking their existing medicines and added Netarsudil — had an average pressure reduction of about 17.0%. It is important to note that these figures describe what was measured and recorded in this particular study population. No safety or effectiveness conclusions should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02030886 · results posted 25 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 14 who had elevated eye pressure (called ocular hypertension) but did not go on to develop glaucoma (the "non-converters"), and 6 who did go on to develop glaucoma (the "converters"). All 20 participants completed the study. The trial was looking at whether a particular pattern in 24-hour eye pressure readings — specifically, the timing of when eye pressure peaked during the day or night, as measured by a contact lens sensor called a Triggerfish (TF) — was linked to which patients later developed glaucoma. The reported data shows that, for the primary outcome, the timing of the eye pressure peak was grouped into two categories: before 7 am or after 7 am. Among the non-converters, 92.3% had their peak before 7 am, compared with 66.7% of converters. Conversely, 7.7% of non-converters had their peak after 7 am, compared with 33.3% of converters. For the secondary outcomes, the reported average time of the eye pressure peak was approximately 5:21 am for non-converters and 6:18 am for converters. The reported average size of the 24-hour eye pressure fluctuation (a measure of how much pressure varied over the day) was 126.9 units for non-converters and 128.0 units for converters. It is worth noting that one participant was removed from all analyses due to a problem with the sensor's output, so the outcome figures are based on 19 participants. The reported numbers are based on a small group of 20 people, and no further detail about statistical significance was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01883856 · results posted 18 September 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 52 people in total, split evenly into two groups of 26. One group received an Ahmed Glaucoma Valve (a small device implanted in the eye to help drain fluid and reduce eye pressure) with a silicone plate, and the other received a version with a porous plate. All 52 participants completed the study. The trial was measuring eye pressure, the number of pressure-lowering eye drops needed, and how many participants met a pre-set definition of "surgical success" at 12 months. The reported data shows that, at the end of the study, the average eye pressure (measured in mmHg, a standard unit for pressure) was 13.60 mmHg in the silicone plate group and 17.94 mmHg in the porous plate group. For the number of glaucoma eye drops being used, the silicone plate group was taking an average of 1.64 medications compared to 1.89 in the porous plate group. Regarding surgical success — defined as eye pressure staying within a target range, no loss of the ability to detect light, and no need for further glaucoma surgery — the reported data shows 23 out of 26 participants in the silicone plate group met this definition, compared to 14 out of 26 in the porous plate group. These figures reflect what was recorded in this specific group of 52 participants over 12 months. The reasons behind any differences between the two groups are not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04454138 · results posted 5 August 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT04454138) enrolled 142 people in total — 65 in one group and 77 in another. The trial compared two different approaches to placing a small device called the XEN-45 gelatin stent, which is used in eye surgery. One group received what is described as a "non-targeted" placement, while the other received a "targeted" placement into a specific area of the eye called the supratenon's space. The trial was measuring changes in eye pressure (the force of fluid inside the eye) after the procedure, comparing results against several different target pressure ranges. The reported data shows the number of participants in each group whose eye pressure fell within various target ranges after surgery. For the strictest target range — eye pressure between 6 and 14 mmHg (millimetres of mercury, the unit used to measure eye pressure) without any eye pressure–lowering medications — 20 out of 65 people in the non-targeted group and 15 out of 77 in the targeted group met that threshold. When medications were allowed to be included, those numbers rose to 33 and 22 respectively. Using a slightly wider target range of 6–17 mmHg without medications, 28 and 18 participants met the threshold; with medications, 41 and 26 did. For the widest range reported (6–21 mmHg), 31 out of 65 in the non-targeted group and 19 out of 77 in the targeted group met the threshold without medications, and 47 and 28 respectively when medications were permitted. The reported data shows only the number of participants reaching each pressure threshold — no other outcome measures or additional detail were submitted in the structured results on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02247804 · results posted 24 April 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 594 people in total — 198 in each of three groups. Participants had raised eye pressure (a condition linked to glaucoma) and were assigned to receive either a small implant containing one of two doses of a medicine called bimatoprost (15 micrograms or 10 micrograms, placed inside the eye), or eye drops containing a comparison medicine called timolol 0.5%. The trial tracked the fluid pressure inside the eye — known as intraocular pressure, or IOP — over three treatment periods, measuring it at several time points across roughly 12 weeks per period. The reported data shows that eye pressure was measured in units called millimetres of mercury (mm Hg). At the 12-week mark, the reported average eye pressure readings were: around 17.5 mm Hg for the bimatoprost 15 μg group, 17.6 mm Hg for the bimatoprost 10 μg group, and 17.9 mm Hg for the timolol drops group. When looking at the change from each participant's starting pressure, the reported figures at week 12 showed reductions of approximately 6.5 mm Hg (15 μg group), 6.4 mm Hg (10 μg group), and 6.1 mm Hg (timolol group) at the first daily time point, and approximately 7.2, 6.7, and 6.5 mm Hg respectively at a second time point two hours later. Earlier readings at weeks 2 and 6 followed a broadly similar pattern across all three groups, as reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01157364 · results posted 30 March 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 109 people in total across six groups. Each group received a small implant placed in the eye that slowly released different doses of a medicine called bimatoprost — either a first-generation or second-generation version of the implant — alongside bimatoprost eye drops (0.03%). The trial was measuring eye pressure (the fluid pressure inside the eye), which is relevant in conditions like glaucoma. The main thing the trial was tracking was how much eye pressure changed from the start of the study to later time points. The reported data shows that at the start of the study, average eye pressure across the six groups ranged from about 23.7 to 26.6 mmHg (millimetres of mercury, the unit used to measure pressure). After treatment, the reported change from that starting pressure ranged from about −5.5 to −8.8 mmHg depending on the group, meaning pressure readings were lower at follow-up than at the start. The reported follow-up pressure readings across all groups ranged from roughly 17.0 to 18.2 mmHg. When eye pressure was averaged across multiple time points during the day (called mean diurnal IOP), the reported figures at follow-up ranged from about 16.4 to 17.9 mmHg, compared to starting values of roughly 20.8 to 23.7 mmHg. The trial also recorded how many days passed before a second treatment or a rescue treatment was needed in the study eye; the reported figures ranged from about 237 days in one group up to approximately 411 days in another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02512042 · results posted 2 March 2020

    According to the results reported on ClinicalTrials.gov, this trial compared a generic version of brinzolamide eye drops (1%) with the brand-name version, Azopt® (also 1%), in people with raised pressure in the eye. A total of 495 people were assigned to the generic drops and 478 to the brand-name drops, with 472 and 453 respectively completing the study. The trial was measuring the pressure inside the eye (called intraocular pressure, or IOP — a measure of how much fluid pressure is building up inside the eyeball) at four specific time points: before and roughly two hours after the morning dose, at both a two-week and a six-week visit. The reported data shows the average eye pressure readings (in millimetres of mercury, mmHg — a standard unit for measuring pressure) at each of the four time points. At the two-week visit before the morning dose, the generic group averaged 19.35 mmHg and the brand-name group averaged 19.75 mmHg. Two hours after the morning dose at that same visit, the generic group averaged 18.53 mmHg and the brand-name group averaged 18.66 mmHg. At the six-week visit before the morning dose, the averages were 18.70 mmHg (generic) and 19.18 mmHg (brand-name). Two hours after the morning dose at six weeks, the averages were 17.94 mmHg (generic) and 18.16 mmHg (brand-name). No other outcome measures were included in the data reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02656836 · results posted 5 February 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02656836) involved a single group of 9 people who were asked to measure the pressure inside their own eyes at home using a handheld device called a tonometer. Six participants completed the study and three did not. The trial was looking at whether the pressure readings taken by patients at home matched the readings taken by clinicians in a medical setting — eye pressure (measured in millimetres of mercury, or mmHg) is an important measurement in conditions like glaucoma. The reported data shows that, on average, the home readings differed from the clinic readings by minus 1.85 mmHg — meaning the home device tended to give readings that were slightly lower than those taken in the clinic. This is the only numerical result that was submitted to ClinicalTrials.gov. Two secondary outcomes were also listed: the proportion of patients willing but unable to use the device, and the proportion of patients who experienced an unwanted side effect during the study. However, no numerical data was reported for either of these two outcomes on ClinicalTrials.gov. It is worth noting that this was a very small study with only 9 participants, and the results data submitted appears incomplete. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03310580 · results posted 15 November 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT03310580) enrolled 42 people across three groups: 15 received a lower-strength eye drop called AR-13324 at 0.02%, 15 received a higher-strength version at 0.04%, and 12 received a placebo (a dummy drop with no active ingredient). The trial was primarily measuring eye pressure — known as intraocular pressure (IOP), which is simply the pressure inside the eye — after four weeks of treatment. All but one participant (from the 0.04% group) completed the study. The reported data shows that at the four-week mark, the average daytime eye pressure reading was 14.35 mmHg (millimetres of mercury, the unit used to measure eye pressure) in the 0.02% group, 14.33 mmHg in the 0.04% group, and 17.32 mmHg in the placebo group. The trial also tracked how many days participants were actually exposed to their assigned drops as a secondary measure — the reported data shows this was an average of 27.9 days for the 0.02% group, 26.8 days for the 0.04% group, and 27.4 days for the placebo group, which is broadly in line with the four-week study period. No other secondary outcome data was reported in the structured results submitted to ClinicalTrials.gov, so no further numbers are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02526693 · results posted 23 October 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02526693) enrolled 53 people with glaucoma and 51 people without glaucoma (healthy controls). Four participants did not complete the study, leaving 50 in each group. The trial was measuring differences in how the pupils of the two eyes respond to light — specifically looking at three things: how much each pupil shrinks (amplitude), how quickly it reacts (latency), and how long it stays at its smallest point (duration). The researchers compared these measurements between the left and right eye within each person, to see whether the two eyes responded differently from one another (called "asymmetry"). The reported data shows the following numbers for the difference between the two eyes in each group. For how much the pupil shrank (amplitude asymmetry), the glaucoma group had a reported difference of 0.8 millimetres, while the healthy group had 0.29 millimetres; a second related measurement showed 0.5 mm for the glaucoma group and 0.16 mm for the healthy group. For how quickly the pupil reacted (latency asymmetry, measured in milliseconds — thousandths of a second), the glaucoma group showed a difference of 0.22 milliseconds compared to 0.14 milliseconds in the healthy group; a second related measurement showed 0.20 ms versus 0.13 ms. For how long the pupil stayed at its smallest point (duration asymmetry), the glaucoma group had a reported value of 2.23 milliseconds compared to 1.92 milliseconds in the healthy group. It is worth noting that the data as submitted appears to include two separate measurements for the first two outcomes but only one for the third; no further breakdown was provided in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01527682 · results posted 27 September 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01527682) enrolled 37 participants who were given a combination of two eye drops — latanoprost and dorzolamide — used together. The trial ran over three years and was looking at whether this combination could lower the pressure inside the eye (called intraocular pressure, or IOP — the fluid pressure that builds up in the eye) by a meaningful amount. Of the 37 people who started, 29 completed the study and 8 did not finish. The reported data shows that for the main question the trial was asking — how many eyes had their pressure reduced by at least 20% from the starting level and kept it there across the full three years — the answer recorded was 33 eyes. For one of the secondary measures, "time to treatment failure" (meaning how long before the medication was considered no longer keeping pressure under control), the data was not reported. The reported data also shows that 61 eyes had at least one recorded adverse event (an unwanted or unexpected occurrence during the study), which the trial monitored for things such as eyelash growth, changes in eye colour, corneal surface issues, and allergic reactions of the eye. It is worth noting that the trial included only one group — everyone received the same combination of medications — so there was no comparison group, which means the numbers above describe only what was observed in this one group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02526654 · results posted 16 September 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02526654) enrolled 115 participants in total — 79 people with glaucoma and 36 healthy volunteers (used as a comparison group). All 115 participants completed the study with no drop-outs recorded. The trial was measuring how well two different visual field testing machines — the Heidelberg Edge Perimeter (HEP) and the Octopus Visual Field (OVF) device — compared to each other in detecting glaucoma. It also looked at how consistently a scanning technology called Optical Coherence Tomography (OCT) produced the same measurements when repeated over time, and how well automated computer reports from the machines matched the judgements of experienced eye specialists. The reported data shows that when comparing the two visual field machines, the correlation (a measure of how closely two sets of numbers move together, on a scale from −1 to +1) between them was −0.86 for the glaucoma group and −0.37 for the healthy control group. For the repeat-testing part of the study, OCT measurements of a specific nerve tissue thickness (called minimum rim width) produced an intraclass correlation coefficient (ICC — another measure of agreement, where scores above 0.75 are described by the researchers as "excellent") of 0.99 for both the glaucoma group and the healthy control group. The reported data also shows that when the automated computer reports were compared to the opinions of three glaucoma specialists, the level of agreement (measured by a "kappa" score, where higher means more agreement) was 0.62 for the glaucoma group — which the researchers' own scale would place in the "fair to good" range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01507584 · results posted 11 September 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01507584) enrolled participants to study eye pressure (intraocular pressure, or IOP — the pressure inside the eye) over a 24-hour period. The trial aimed to look at how eye pressure changes between daytime and night-time, and how it responds to a test called the Water Drinking Test (where a person drinks a set amount of water quickly to see how it affects eye pressure). Eye pressure was to be monitored at roughly four-week intervals using a wearable device. The reported data shows that zero participants were recorded as having started, completed, or left the study early. Because no participants appear to have been enrolled, the reported results contain no measurement data for any of the outcomes — not for the 24-hour eye pressure patterns, not for the ongoing eye pressure monitoring sessions, and not for the tracking of any eye-related unwanted events. In other words, no numerical findings were submitted for any of the trial's planned measurements. The reported data does not explain why no participants were enrolled or why no results were recorded — that information was not included in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01551550 · results posted 11 September 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 82 people with glaucoma who needed a small drainage device (called a glaucoma drainage device, or GDD) implanted in their eye to help manage eye pressure. The participants were split into two equal groups of 41: one group had the device covered with a patch made from amniotic membrane (tissue from the lining of a placenta), and the other group had it covered with a patch made from pericardial tissue (the fibrous sac surrounding the heart). The trial was primarily looking at whether the tube of the drainage device wore through or became exposed under the skin of the eye — a complication called tube erosion. The reported data shows that, over the course of the study, 2 out of 41 participants in the amniotic membrane patch group experienced tube erosion, compared with 11 out of 40 participants in the pericardial patch group. For the secondary outcome — how many participants experienced overall device failure (defined as the eye pressure remaining too high or too low, needing further glaucoma surgery, or losing all light perception) — the reported data shows 2 participants in each group met the criteria for device failure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03233308 · results posted 11 June 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, with 18 completing the study and 2 not completing it. All participants were grouped together as a single randomised group. The trial was measuring how a eye drop medicine called Netarsudil (0.02% solution) compared to a placebo (an inactive dummy drop) in terms of how well fluid drains from the eye — specifically through a pathway called the trabecular outflow facility — as well as the pressure in certain eye veins (episcleral venous pressure) and the overall pressure inside the eye (intraocular pressure, or IOP). The reported data shows that, for the main (primary) outcome — the change in fluid drainage through the trabecular pathway — the Netarsudil group showed an average increase of 0.039 mcl/min/mmHg (a unit measuring fluid flow against pressure), compared to 0.007 in the placebo group. In percentage terms, this represented an average change of about 34.6% in the Netarsudil group versus about 9.6% in the placebo group. For the secondary outcomes, the reported data shows the Netarsudil group had an average change in eye vein pressure of −0.787 mmHg (millimetres of mercury, a pressure unit) compared to +0.103 mmHg in the placebo group, noting this measurement was only taken in 9 participants at one site. For eye pressure overall (IOP), the Netarsudil group showed an average change of −4.521 mmHg (about −19.6%) compared to −0.979 mmHg (about −4.2%) in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02558400 · results posted 4 June 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 718 adults across three groups to compare the effects of three different eye drops on eye pressure (the force of fluid inside the eye, measured in units called mmHg — millimetres of mercury). The three treatments were: a combination drop called PG324 (238 participants), a drop called AR-13324 alone (244 participants), and a drop called latanoprost alone (236 participants). Not everyone finished the study — 159, 148, and 203 participants respectively completed the full course in each group. The reported data shows that eye pressure was measured at three different times of day (8am, 10am, and 4pm) at three points during the study (Day 15, Day 43, and Day 90). At the start, all three groups had very similar average eye pressure readings, around 24.6–24.8 mmHg. By Day 15 the readings had moved to roughly 23.4–23.7 mmHg across all groups. By Day 43, the combination drop group and the AR-13324 group were reported at around 22.6 mmHg, while the latanoprost group was reported at 23.4 mmHg. By Day 90, the combination drop group showed a reported average of 15.68 mmHg, compared with 18.66 mmHg for the AR-13324 group and 17.74 mmHg for the latanoprost group. The reported data also shows that on average, participants used their eye drops for roughly 276 days (combination group), 266 days (AR-13324 group), and 330 days (latanoprost group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02674854 · results posted 1 May 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 750 people across three groups: 245 received a combination eye drop called PG324 (0.02%/0.005%), 255 received netarsudil eye drops (0.02%) alone, and 250 received latanoprost eye drops (0.005%) alone. The trial was measuring eye pressure — known as intraocular pressure (IOP), which is the pressure inside the eye — at several points in time over 90 days. By the end of the study, 221, 228, and 236 participants in each group respectively had completed the trial. The reported data shows that before treatment began, average eye pressure across all three groups was very similar, sitting between roughly 24.7 and 24.8 mmHg (millimetres of mercury, the unit used to measure eye pressure). The reported data shows that over the course of the study, average eye pressure readings fell across all three groups. At the 90-day mark, the combination drop group (PG324) recorded an average eye pressure of 16.06 mmHg, compared to 19.35 mmHg in the netarsudil-only group and 18.10 mmHg in the latanoprost-only group. These are the averages across all three measured time points in the day at the 90-day visit, as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02622191 · results posted 27 February 2019

    According to the results reported on ClinicalTrials.gov, this trial included 33 people in total — 19 with open-angle glaucoma and 14 healthy individuals used as a comparison group. All 33 participants completed the study with no drop-outs. The trial was measuring a structure at the back of the eye called the lamina cribrosa, which sits at the boundary of the retinal layers. Researchers used a specialised eye-scanning technology (called Spectral Domain optical coherence tomography, or SD-OCT) to take detailed measurements of this structure across the different groups. The reported data shows that the thickness measurements — recorded in micro-ohms (a unit of measurement used in this context) — were fairly similar across all three groups examined. The affected eyes of people with glaucoma had a reported measurement of 264.3 micro-ohms, the healthy control group measured 273.3 micro-ohms, and the unaffected ("fellow") eyes of the glaucoma participants measured 276.2 micro-ohms. No additional secondary outcome data was reported in the structured results submitted to ClinicalTrials.gov. It is worth noting that the unit listed in the data — "micro-ohms" — is unusual for an eye thickness measurement, and may reflect a data entry issue in the submission; the actual unit used in the scan is not entirely clear from what was reported. The reported data shows only what was submitted, and no further clarification was provided in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02537015 · results posted 26 February 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 81 people who received a bimatoprost ocular insert (a small device placed in the eye) as part of an extended study. Of those 81 participants, 75 completed the trial and 6 did not. The trial was primarily measuring how often participants experienced unwanted medical events — known as adverse events — in the eye and elsewhere in the body, and how serious those events were. The reported data shows that for ocular (eye-related) adverse events, 25.9% of participants experienced a mild event, 11.1% experienced a moderate event, and 0% experienced a severe event. For non-ocular (events occurring outside the eye), 6.2% of participants experienced a mild event, 8.6% experienced a moderate event, and 4.9% experienced a severe event. Several other measurements were listed in the trial — including changes in eye pressure, participant comfort ratings, how long the inserts stayed in place, whether anyone needed additional treatment, and changes in eye cell counts — however, no numerical results for those outcomes were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02622178 · results posted 15 November 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 136 people across three groups: 42 healthy participants, 45 people considered "glaucoma suspects" (meaning they had some features that may be associated with glaucoma but no confirmed diagnosis), and 49 people with a confirmed glaucoma diagnosis. All 136 participants completed the study with no dropouts. The trial was measuring two things: the strength of the brain's electrical response to visual signals (called a Visual Evoked Potential, or VEP), and the thickness of a layer of nerve fibres at the back of the eye. The reported data shows that when the brain's electrical response to visual signals was measured, the healthy group recorded an average strength of 6.7 microvolts, the glaucoma suspects group recorded 7.1 microvolts, and the glaucoma patients group recorded 4.1 microvolts. For the second measure — the thickness of the nerve fibre layer at the back of the eye — the reported data shows an average of 95.1 microns in the healthy group, 87.5 microns in the glaucoma suspects group, and 71.2 microns in the glaucoma patients group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01749904 · results posted 7 November 2018

    According to the results reported on ClinicalTrials.gov, this trial compared two eye pressure-lowering treatments — an investigational medicine called BOL-303259-X and an existing medicine called Timolol — in people with raised pressure in the eye (a condition often associated with glaucoma). A total of 420 participants were enrolled: 286 in the BOL-303259-X group and 134 in the Timolol group. Of those, 264 and 123 respectively completed the study. The main thing being measured was the average pressure inside the eye (called intraocular pressure, or IOP) at nine set time points across three months. The reported data shows that, across all nine measurement points, the average eye pressure readings in the BOL-303259-X group ranged from approximately 17.8 to 18.6 mmHg (millimetres of mercury, the unit used to measure eye pressure), while the Timolol group's readings ranged from approximately 19.1 to 19.8 mmHg. For the secondary outcomes, the reported data shows that 65 participants in the BOL-303259-X group had eye pressure consistently at or below 18 mmHg across all nine time points, compared with 15 in the Timolol group. Additionally, 99 participants in the BOL-303259-X group had a consistent pressure reduction of 25% or more across all nine time points, compared with 26 in the Timolol group. The trial also recorded the number of participants who experienced unwanted side effects (called adverse events), with 36 and 38 participants in the BOL-303259-X and Timolol groups respectively reporting eye or body-related adverse events during the main comparison phase; figures for a later open-label extension phase (where all participants received BOL-303259-X) were also reported but relate to a separate study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02558374 · results posted 6 April 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 708 people in total — 351 in one group and 357 in the other. One group used AR-13324 Ophthalmic Solution 0.02% (an eye drop) alongside a placebo, while the other group used Timolol Maleate Ophthalmic Solution 0.5% twice daily (an existing eye drop medicine). The trial was measuring eye pressure, known as intraocular pressure (IOP) — that is, the pressure inside the eye — across several time points. Not everyone finished the study: 243 people in the first group and 314 in the second group completed it. The reported data shows that eye pressure readings (measured in mmHg — millimetres of mercury, a standard unit for pressure) were tracked at multiple points over the course of the study. At the start, both groups had very similar average eye pressures of around 23.9 mmHg. The reported numbers then show a gradual reduction over time in both groups across the measurement points: the AR-13324 group's average readings moved from approximately 23.9 down through 22.7, 22.2, 19.2, 17.9, and finally 17.8 mmHg. The Timolol group's readings followed a similar pattern, moving from approximately 23.9 down through 22.8, 22.0, 18.6, 17.8, and finally 17.9 mmHg. These are simply the numbers recorded at each time point — no comparison or conclusion about which approach performed better is made here. The reported data also shows that, on average, participants in the AR-13324 group were exposed to their study medication for about 147 days, while those in the Timolol group were exposed for about 168 days. No other secondary outcome figures were included in the data submitted to ClinicalTrials.gov, so further details are not available to report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01528787 · results posted 22 February 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01528787) enrolled 85 people across four groups to compare three different concentrations of an eye drop called AR-13324 against a vehicle (a plain drop containing no active ingredient, used as a comparison). The groups received either the 0.01%, 0.02%, or 0.04% strength of AR-13324, or the vehicle. The main thing being measured was eye pressure — known as intraocular pressure (IOP), measured in millimetres of mercury (mmHg) — at several time points over eight days. Nearly all participants completed the study, with only one person in the 0.04% group and one in the vehicle group not finishing. The reported data shows the eye pressure readings taken at three time points on Day 8 (at 8:00 am, 10:00 am, and 12:00 pm). At 8:00 am on Day 8, the average eye pressure readings were 22.45 mmHg for the 0.01% group, 22.10 mmHg for the 0.02% group, 24.29 mmHg for the 0.04% group, and 22.87 mmHg for the vehicle group. At 10:00 am, the reported figures were 21.93 mmHg, 21.95 mmHg, 25.00 mmHg, and 22.91 mmHg respectively. The starting (Day 2 pre-treatment) eye pressure readings were also reported, sitting in the range of approximately 25 to 26.5 mmHg across all four groups. No data for the 4:00 pm reading or the Day 4 reading appears to have been included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02036541 · results posted 1 June 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 65 people who all received a device called the XEN 45 Gel Stent, which is a small implant used in the eye for glaucoma. The trial was measuring two things: how many participants had their eye pressure (a key measurement in glaucoma management) drop by at least 20% from their starting level while using the same or fewer eye pressure medications, and by how much eye pressure changed on average over 12 months. Of the 65 people who started, 54 reached the main measurement visit and 49 completed the full study. The reported data shows that 46 out of 65 participants met the target of a 20% or greater reduction in eye pressure while using the same or fewer medications at the 12-month mark. Participants who needed an additional glaucoma-related procedure before the 12-month visit were counted as not meeting this target. The reported data also shows that, on average, eye pressure fell by 6.2 mmHg (millimetres of mercury, the unit used to measure eye pressure) from where it started at the beginning of the trial. It is worth noting that this trial had only one group — everyone received the XEN 45 Gel Stent — so there was no comparison group receiving a different treatment or no treatment. The numbers above describe what was observed in this single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01085357 · results posted 20 October 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01085357) enrolled 505 people in total — 374 in the group that received a CyPass Micro-Stent inserted at the same time as cataract surgery, and 131 in the group that had cataract surgery alone. Of those, 355 and 125 participants respectively completed the study. The trial was measuring eye pressure (the fluid pressure inside the eye, sometimes called IOP) over two years, looking at whether pressure levels changed and whether they fell within a target range, all assessed without the use of pressure-lowering eye drops at the time of measurement. The reported data shows that for the main outcome — the proportion of eyes whose pressure dropped by at least 20% from the starting level by the two-year mark — 72.5% of eyes in the CyPass plus cataract surgery group met this threshold, compared with 58.0% of eyes in the cataract surgery-only group. For the secondary outcomes, the reported average reduction in eye pressure from the starting level was 7.0 mmHg (millimetres of mercury, the unit used to measure eye pressure) in the CyPass group and 5.3 mmHg in the cataract-surgery-only group — where a larger number indicates a greater reduction. A further secondary measure looked at the proportion of eyes that landed within a specific pressure range (between 6 and 18 mmHg) at two years: the reported data shows 61.2% of eyes in the CyPass group and 43.5% of eyes in the cataract-surgery-only group fell within that range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00661583 · results posted 13 October 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total, split evenly into three groups of 10: one group received a medicine called ranibizumab on its own, one received ranibizumab combined with another medicine called MMC (mitomycin C), and one received MMC alone. All 30 participants completed the study. The trial was looking at eye-related unwanted events (adverse events) as its main focus, and also tracked eye pressure, a measure of vision sharpness, and whether a small fluid pocket in the eye called a "bleb" — which is created during glaucoma surgery to help drain fluid — remained healthy and working at six months. The reported data shows that the number of recorded eye-related adverse events was zero across all three groups. For the secondary measures, 100% of participants in every group met the definition of a "qualified success" — meaning their eye pressure stayed within a target range (between 6 and 22 mmHg, with or without additional pressure-lowering medicines) and their bleb was still viable at six months. Regarding eye pressure changes, the reported data shows reductions in all three groups. At three months, the ranibizumab-alone and combination groups both showed an average drop of about 6.4 mmHg, while the MMC-alone group showed a drop of about 8.35 mmHg. At six months, the reported drops were approximately 6.6 mmHg (ranibizumab alone), 4.9 mmHg (combination), and 8.0 mmHg (MMC alone). For vision sharpness — measured on a scale where smaller numbers generally indicate better vision — the reported changes were small across all groups at both time points, though the exact timing breakdown for these figures was not separately labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02003391 · results posted 8 August 2016

    According to the results reported on ClinicalTrials.gov, this trial compared two eye drop treatments for people with raised eye pressure — a condition linked to glaucoma. One group received DuoTrav and the other received a beta-blocker (a type of eye drop commonly used to lower eye pressure). A total of 81 people started in the DuoTrav group and 75 in the beta-blocker group, with 78 and 73 respectively completing the trial. The trial was measuring the pressure inside the eye (called intraocular pressure, or IOP), which is simply the fluid pressure within the eyeball, recorded in units called mmHg (millimetres of mercury). The reported data shows that, at the 8am measurement point, the DuoTrav group had an average eye pressure reading of 16.6 mmHg, while the beta-blocker group had an average reading of 21.2 mmHg. Looking at how much each group's eye pressure changed from their starting point over four weeks, the DuoTrav group's pressure fell by an average of 5.84 mmHg, compared to a fall of 1.07 mmHg in the beta-blocker group. The reported data also shows this as a percentage change: the DuoTrav group's eye pressure dropped by approximately 25.4% from their starting level, while the beta-blocker group's dropped by approximately 4.7%. As noted in the trial data, a negative change in these figures means a reduction in eye pressure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00947661 · results posted 30 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 289 participants in each of two groups — one group received a treatment referred to as "SPARC0912" and the other received a "Reference" treatment — giving a total of 578 participants. The trial was measuring changes in eye pressure (called intraocular pressure, which is simply the pressure inside the eye) over 12 weeks. Most participants completed the study: 276 in the SPARC0912 group and 274 in the Reference group. The reported data shows that the primary outcome — how much eye pressure dropped from the start of the study to Week 12 — was measured in units called millimetres of mercury (mm Hg), a standard way of measuring pressure. According to the results reported on ClinicalTrials.gov, the average reduction in eye pressure was 6.12 mm Hg in the SPARC0912 group and 6.91 mm Hg in the Reference group. No additional breakdown of results across the 12 individual time points was included in the submitted data. Secondary outcome measure data was not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00945958 · results posted 5 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 161 participants in a single group, all receiving the same treatment (labelled SPARC0913). The trial had two main focuses: tracking any unwanted or unexpected health events (called adverse events) that participants experienced during the study, and measuring changes in eye pressure (known as intraocular pressure, or IOP — the pressure inside the eye) over a 24-week period. Of the 161 people who started, 149 completed the trial, and 12 did not finish. The reported data shows that 140 out of 161 participants experienced at least one treatment-related adverse event during the study period. Regarding eye pressure, the reported data shows an average change of 2.83 mmHg (millimetres of mercury, the unit used to measure eye pressure) from the start of the study to the end at week 24. The direction of that change — that is, whether eye pressure went up or down on average — was not clearly specified in the data as submitted, so that detail cannot be confirmed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02105272 · results posted 17 November 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 237 people in total — 118 in the OPC-1085EL eye drop group and 119 in the latanoprost eye drop group. Both are types of eye drops being studied in relation to intraocular pressure, which is the pressure inside the eye. The trial ran for 8 weeks and was measuring how much that pressure changed from the start of the study to the end, as well as what the pressure levels were at specific time points during week 8. The reported data shows that the main (primary) outcome — the average reduction in eye pressure from the beginning of the study — was 2.9 mmHg (millimetres of mercury, the unit used to measure eye pressure) in the OPC-1085EL group and 1.6 mmHg in the latanoprost group. For the secondary outcomes, the reported eye pressure readings at week 8 before a dose was given were 17.1 mmHg for OPC-1085EL and 18.4 mmHg for latanoprost. At 2 hours after a dose, the reported readings were 17.2 mmHg and 18.2 mmHg respectively. At 8 hours after a dose, the readings were 16.7 mmHg and 17.4 mmHg. The reported reductions from baseline at 2 hours after dosing were 2.1 mmHg for OPC-1085EL and 1.0 mmHg for latanoprost, and at 8 hours after dosing were 1.7 mmHg and 1.0 mmHg respectively. It is worth noting that the reported data explains that the number of participants included in the pressure measurements was slightly smaller than the total who started the trial, because some participants were excluded from the analysis in line with the pre-planned rules — for example, those who had no pressure measurement recorded after receiving the drops. No other outcome data beyond these pressure measurements was included in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01995136 · results posted 20 July 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants, all of whom received a eye drop treatment called TRAVATAN Z. Thirty-one participants completed the trial, while one did not finish. The trial was measuring changes in eye pressure — known as intraocular pressure (IOP), which is the fluid pressure inside the eye — over a 12-week period, with check-ins at weeks 4, 8, and 12. The reported data shows that, at the start of the trial (called "baseline"), the average eye pressure in the study eye was 16.55 mmHg (millimeters of mercury, the unit used to measure eye pressure). Across the three check-in points at weeks 4, 8, and 12 combined, the average change from that starting point was -3.37 mmHg — meaning eye pressure was, on average, 3.37 units lower than where it began. In this context, a negative number indicates a reduction in eye pressure from the baseline measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00869141 · results posted 17 June 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total — 26 in a "Research Arm" and 26 in a "Standard of Care Arm." All 52 participants completed the study. The trial was looking at what happens to eye pressure after a device called an Ahmed valve is surgically implanted to treat glaucoma (a condition where pressure inside the eye can damage vision). Specifically, it was measuring how often participants experienced a "hypertensive phase" — a period in the first six months after surgery where eye pressure rose above a certain level after initially being well controlled. The reported data shows that in the Research Arm, 9 out of 26 participants experienced this hypertensive phase, compared with 12 out of 26 in the Standard of Care Arm. When eye pressure was measured at around three weeks after surgery, the Research Arm recorded an average of 15.6 mmHg (millimetres of mercury — a standard unit for measuring eye pressure), while the Standard of Care Arm recorded an average of 20.6 mmHg. The trial also compared eye pressure at one year after surgery between those who had experienced the hypertensive phase and those who had not — across both groups combined, those who had the hypertensive phase recorded an average of 15.1 mmHg, while those who did not had an average of 11.4 mmHg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01937312 · results posted 8 June 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01937312) enrolled 94 people in the SIMBRINZA group and 95 people in the vehicle (inactive comparator) group, for a total of 189 participants. The trial was measuring fluid pressure inside the eye — known as intraocular pressure, or IOP — over six weeks. Eye pressure was checked at four times during the day (8 am, 10 am, 3 pm, and 5 pm), and researchers tracked both the actual pressure readings and how much those readings changed from each participant's starting level. The reported data shows that at week six, the average daytime eye pressure in the SIMBRINZA group was 17.01 mmHg (millimetres of mercury, the unit used to measure eye pressure), compared with 20.37 mmHg in the vehicle group. For the change from the starting pressure, the SIMBRINZA group showed an average reduction of 5.69 mmHg, while the vehicle group showed an average reduction of 1.99 mmHg. In percentage terms, the reported data shows the SIMBRINZA group's pressure fell by an average of about 24.9%, compared with about 8.5% in the vehicle group. When looking at individual time points at week six, the reported eye pressure readings for the SIMBRINZA group were 19.4 mmHg at 8 am, 15.8 mmHg at 10 am, 17.2 mmHg at 3 pm, and 15.6 mmHg at 5 pm; the corresponding figures for the vehicle group were 21.4, 20.2, 19.9, and 19.9 mmHg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01735214 · results posted 27 April 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 358 people who had been diagnosed with either primary open-angle glaucoma (a common form of glaucoma where fluid pressure builds up in the eye) or ocular hypertension (higher-than-normal eye pressure without glaucoma damage). All 358 participants completed the study. The trial was looking at changes in the fluid pressure inside the eye (called intraocular pressure, or IOP) after switching to a new pressure-lowering eye medication, as well as how patients and their doctors rated the tolerability of and adherence to that new treatment over 12 weeks. The reported data shows that, on average, the fluid pressure in participants' right eyes dropped by 4.5 mmHg (millimetres of mercury, the unit used to measure eye pressure) from where it started — a negative number here means pressure went down. When participants rated how well they tolerated the new treatment, 48.6% said "very good" and 31.6% said "good," while 6.1% said "moderate" and 1.7% said "poor"; the remaining 12.0% were not reported in a category. Doctors' tolerability ratings were similar: 50.0% "very good," 33.0% "good," 4.7% "moderate," and 2.2% "poor," with 10.1% not categorised. Regarding how well participants stuck to using the new treatment, doctors rated 41.34% as "better" adherence, 42.74% as "equal," 4.47% as "worse," 1.68% as "not applicable," and 9.78% were not placed in a category. The reported data also shows that 7.5% of participants stopped using the new treatment before the 12 weeks were up, while 83.5% were reported to be continuing with it after 12 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01658839 · results posted 21 July 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom completed the study with no drop-outs. The trial involved a single group who received travoprost (an eye drop medication). The study was focused on measuring how much of the drug's active form — called travoprost free acid — entered the bloodstream after dosing, and how quickly it moved through the body. Blood samples were taken before the dose and at 10, 20, 40, and 80 minutes after dosing to track these changes over time. The reported data shows that the peak amount of the active substance detected in the blood (the highest concentration reached) ranged across reported figures from approximately 0.011 to 0.047 nanograms per millilitre — these are very small quantities. The time it took to reach that peak level was reported as roughly 0.17 to 0.39 hours (around 10 to 23 minutes) after dosing. The last point at which the substance could still be measured in the blood occurred at around 0.34 to 0.46 hours (roughly 20 to 28 minutes) after dosing. Measures of the total exposure to the drug over time (known as "area under the curve," which reflects how much of the substance was in the blood and for how long) were also reported as very small values. The reported half-life — meaning the time it took for the concentration in the blood to reduce by half — was approximately 0.53 hours (about 32 minutes) in the participants for whom this could be calculated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00345046 · results posted 21 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people across three groups, each receiving a different brand or formulation of prednisolone acetate 1% eye drops — called Pred Forte, EconPred Plus, and a generic prednisolone acetate. The trial was measuring changes in eye inflammation (specifically something called "flare," which refers to cloudiness or haziness inside the eye caused by inflammation) by the time the condition had resolved. Most participants completed the study: 17 out of 18 in the Pred Forte group, 21 out of 22 in the EconPred Plus group, and 14 out of 16 in the generic prednisolone acetate group. The reported data shows that the primary outcome — the percentage change in eye flare at the point of resolution — was broadly similar across all three groups. The Pred Forte group showed a reported 64.8% change in flare, the EconPred Plus group showed 68.3%, and the generic prednisolone acetate group showed 65.7%. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01518244 · results posted 4 April 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people who were using AZARGA® (a type of eye drop). The trial was measuring the pressure inside the eye — known as intraocular pressure, or IOP — which is the fluid pressure that builds up inside the eye. The main question the trial was looking at was how much that pressure changed after 8 weeks of treatment. Of the 50 people who started, 47 completed the trial and 3 did not. The reported data shows that, on average, eye pressure in the study eye dropped by 3.60 mmHg (millimetres of mercury, a standard unit for measuring pressure) from the starting level after 8 weeks. A negative number here means the pressure went down compared to where it started. The trial also measured how many participants reached a target eye pressure of 18 mmHg or below — a level considered a goal in managing eye pressure. The reported data shows that 55.3% of participants reached that target pressure level at the 8-week mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01390779 · results posted 20 January 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 33 people who wore a device called the SENSIMED Triggerfish — a special contact lens sensor designed to monitor pressure-related changes in the eye over time. Thirty-two of the 33 participants completed the trial. The trial was measuring two things: first, whether the device could pick up changes in eye pressure between waking and sleeping hours; and second, whether the device could detect a pulse-like signal in the eye that matches a person's heart rate. The reported data shows that, for the first measurement, the device recorded an average slope of 56.9 millivolts per hour (this is a unit describing the direction and size of the change the sensor picked up over time) in the participants included in that part of the analysis. Some participants were left out of this analysis — one because their eye pressure did not change by at least 3 mmHg (millimetres of mercury, a standard unit for eye pressure) between waking and sleeping, two because not enough sensor data was collected, and one due to an invalid recording. For the second measurement, the reported data shows that 86.5% of the recording intervals analysed showed the device picking up an oscillating signal that matched the participant's heart rate within a 15% margin — the trial had set a target of at least 75% for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01514734 · results posted 21 October 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT01514734) involved just 9 participants, all of whom were in a single group receiving a treatment called AZARGA (a eye drop used in the context of glaucoma-related conditions). All 9 participants completed the study, with none dropping out. The trial was measuring changes in eye pressure — known as intraocular pressure, or IOP — which is the pressure inside the eye. Eye pressure is relevant because higher levels can be associated with a greater risk of damage to the optic nerve over time. The reported data shows that the primary outcome — the change in eye pressure after 8 weeks compared to where participants started (their baseline, meaning their pressure while on their prior therapy) — was a reduction of 0.89 mmHg (millimetres of mercury, the unit used to measure eye pressure) on average in the AZARGA group. This figure comes from measurements taken in each participant's worse-affected eye. It is worth noting that this was a very small study with only 9 people, and no comparison or control group was included in the reported data. Secondary outcome results were not reported in the data submitted to ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01426867 · results posted 8 July 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people across three groups: 33 received a combination eye drop (Brinzolamide/Brimonidine, referred to as "Brinz/Brim"), 34 received Brinzolamide alone, and 34 received Brimonidine alone. All 101 participants completed the study with no dropouts reported. The trial was measuring eye discomfort felt by participants shortly after using their assigned eye drop, rated on a simple 5-point scale from 0 (no discomfort at all) to 4 (very severe discomfort). The reported data shows that average discomfort scores across the three groups were all at the lower end of the scale. The combination drop (Brinz/Brim) group had an average score of 0.8 out of 4, the Brinzolamide-only group had an average score of 0.4 out of 4, and the Brimonidine-only group had an average score of 0.3 out of 4. In plain terms, all three groups reported scores that sit between "none" and "mild" on average, with the combination group reporting a slightly higher average discomfort score than either of the individual drops used alone. No other outcome measures were included in the data submitted to ClinicalTrials.gov for this trial, so no further results can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01336569 · results posted 8 July 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT01336569) enrolled 49 people who were already using a beta-blocker eye drop medication and were then switched to a combination eye drop called DuoTrav. The trial was measuring changes in eye pressure — known as intraocular pressure, or IOP — which is simply the pressure inside the eye. Raised eye pressure can be a risk factor for a condition called glaucoma, which can damage the optic nerve over time. Of the 49 people who started the trial, 45 completed it, and 4 did not finish. The reported data shows that the main thing being measured was the change in eye pressure between the start of the trial (while participants were still on their beta-blocker medication) and the final visit (after using DuoTrav). Eye pressure was measured in units called millimetres of mercury (mmHg). According to the results reported on ClinicalTrials.gov, the average change in eye pressure at the final visit was minus 5.0 mmHg — meaning that, on average, eye pressure readings were 5.0 mmHg lower at the end of the study compared to the starting point. A negative number here indicates a reduction in eye pressure from baseline. No secondary outcome measure data was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00800540 · results posted 22 March 2013

    According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning participants tried both treatments in sequence, with a washout break in between. A total of 35 people were enrolled across two groups: 17 started on a eye drop medicine called AZARGA before switching to COMBIGAN, and 18 started on COMBIGAN before switching to AZARGA. The trial was measuring changes in blood flow and pressure inside and around the eye over six weeks on each treatment. Specifically, it looked at something called diastolic ocular perfusion pressure (DOPP) — a measure of the blood supply reaching the optic nerve, calculated by comparing blood pressure and eye pressure — as well as blood flow in the retina (the light-sensitive layer at the back of the eye) and the pressure inside the eye itself. The reported data shows that for the main outcome — the overall change in DOPP after six weeks — participants on AZARGA showed an average increase of 2.6 mmHg (millimetres of mercury, a unit of pressure), while those on COMBIGAN showed an average increase of 0.8 mmHg. For eye pressure (measured at multiple points over 24 hours), both groups showed reductions across all timepoints, ranging roughly from around −1.3 to −6.3 mmHg for AZARGA and −0.6 to −6.5 mmHg for COMBIGAN. The reported data also shows changes in diastolic blood pressure across the day and night, with figures varying across timepoints for both groups. For the retinal blood flow measurements (reported in arbitrary units rather than a standard medical unit), the numbers varied considerably across the four timepoints measured, with some timepoints showing increases and others showing decreases for both treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01177098 · results posted 12 March 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 561 people in total — 278 in one group and 283 in the other. Both groups used eye drops that combined two medicines (bimatoprost and timolol) to manage fluid pressure inside the eye, which is relevant to conditions like glaucoma. The two groups received slightly different versions of the same combination drop. The trial mainly measured the fluid pressure (called intraocular pressure, or IOP) inside the eye at several points in the day — at the start of the study and again at 2, 6, and 12 weeks. Most participants completed the trial: 269 in the first group and 271 in the second. The reported data shows that, at the start of the study, the average pressure in the more affected eye was around 25 mm Hg (millimetres of mercury, the unit used to measure eye pressure) in both groups. After 12 weeks, the reported change in that eye's pressure was a reduction of approximately 9.1 mm Hg for Formulation A and 8.7 mm Hg for the existing combination drop, measured at the first time point of the day. Similar reductions were recorded at the other two time points during the day. When looking at the average pressure across both eyes over the 12-week period, both groups recorded average eye pressure readings in the range of roughly 15.8 to 16.6 mm Hg at the various check-in times across weeks 2, 6, and 12. The reported data shows that both groups had broadly similar pressure readings across all the time points measured, though the exact numbers varied slightly between the two formulations at each check. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information is not available here to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01253902 · results posted 7 November 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 164 people across three groups, each using a different eye drop medicine: 56 people used bimatoprost 0.01%, 53 used travoprost 0.004%, and 55 used latanoprost 0.005%. These are all eye drops commonly used to reduce pressure inside the eye. The trial ran for 12 weeks and was measuring things related to eye surface health — specifically, redness of the eye's surface, tiny disruptions on the clear front surface of the eye (detected using a special dye), and how quickly the eye's tear film broke down after blinking. By the end of the study, 51 participants in each group had completed the trial. The reported data shows that at 12 weeks, average eye redness scores (on a scale from 0 = none to 3 = severe redness) were 0.42 for the bimatoprost group, 0.46 for the travoprost group, and 0.44 for the latanoprost group — all sitting between "no redness" and "trace redness" on the scale. For the surface disruption measure (also scored 0 to 3), the reported averages were 0.31, 0.32, and 0.22 for the three groups respectively, again all at the lower end of the scale. The reported data shows tear film stability — measured as the time in seconds before dry spots appeared on the eye — averaged 9.7 seconds for both the bimatoprost and travoprost groups, and 9.3 seconds for the latanoprost group. These numbers describe what was observed and recorded in the trial at a single point in time, and no comparison between groups has been described here beyond the raw figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00761319 · results posted 23 April 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 705 people in total — 353 in the travoprost group and 352 in the latanoprost group. Both travoprost and latanoprost are eye drops used to treat raised pressure in the eye. The trial was measuring changes in eye surface discomfort and signs of eye surface irritation over 90 days, using a patient-completed questionnaire and an eye examination. By the end of the study, 305 people in the travoprost group and 318 in the latanoprost group had completed the trial. The reported data shows that the main thing being measured was a change in a questionnaire score called the OSDI (Ocular Surface Disease Index), which runs from 0 (no problems) to 100 (severe problems). A negative change in score means participants reported fewer symptoms at day 90 compared to the start. The travoprost group showed an average change of –9.1 points, and the latanoprost group showed an average change of –10.2 points. For the secondary measure — the percentage of participants whose eye surface staining test came back completely clear (a score of zero, meaning no visible surface staining detected) — the reported data shows 37.6% in the travoprost group and 38.7% in the latanoprost group achieved this result at 90 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01215786 · results posted 16 January 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total: 21 received a investigational eye drop called AGN-207281, 19 received timolol (an existing eye drop used to lower pressure inside the eye), and 10 received a placebo (a dummy drop with no active ingredient). All 50 participants completed the study. The trial was measuring changes in the fluid pressure inside the eye — known as intraocular pressure, or IOP — over 14 days, as well as how much of the investigational drug was absorbed into the bloodstream. The reported data shows that, at the start of the study, the pressure readings in the worst-affected eye were similar across all three groups (around 26 mm Hg, where mm Hg is the unit used to measure eye pressure). After 14 days, the reported average change from that starting point was a reduction of 4.17 mm Hg in the AGN-207281 group, a reduction of 6.16 mm Hg in the timolol group, and a reduction of 1.10 mm Hg in the placebo group. A negative number here means eye pressure went down from where it started. The reported data also shows that levels of AGN-207281 detected in the bloodstream (measured in the liquid part of the blood) averaged 177 picograms per millilitre at day 7 and 540 picograms per millilitre at day 14, both measured about 15 minutes after the morning dose. No blood-level figures were reported for the timolol or placebo groups, as this measurement was only relevant to the investigational drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01026831 · results posted 13 September 2011

    According to the results reported on ClinicalTrials.gov, this trial compared two eye drop treatments — tafluprost and timolol maleate — in people with elevated eye pressure, which is associated with glaucoma. A total of 320 people were assigned to the tafluprost group and 323 to the timolol maleate group, with 306 and 312 people respectively completing the study. The trial measured changes in eye pressure (the force of fluid inside the eye, measured in units called mmHg) at nine different time points across 12 weeks — at three times of day (8am, 10am, and 4pm) at weeks 2, 6, and 12. The reported data shows that both groups started with similar eye pressure readings at baseline — around 26 mmHg in the morning, 24–25 mmHg at 10am, and 23–24 mmHg in the afternoon. After treatment, the reported data shows reductions in eye pressure across all time points in both groups. For the tafluprost group, the reported reductions ranged from approximately 6.2 to 7.3 mmHg depending on the time point. For the timolol maleate group, the reported reductions ranged from approximately 5.3 to 7.4 mmHg. These are the average changes across participants in each group as submitted to the registry; individual results were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00832377 · results posted 24 March 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people, all of whom received a combination eye drop treatment called timolol/dorzolamide. Thirty-six participants completed the study, and one did not finish. The trial was measuring changes in eye pressure — known as intraocular pressure, or IOP, which is simply the pressure inside the eye — in people with a condition called normal tension glaucoma. Eye pressure was measured at the start of the study (baseline) and again after 12 weeks of treatment, at different times of day. The reported data shows that participants started with an average eye pressure of 15.60 mmHg (millimetres of mercury, the unit used to measure eye pressure). After 12 weeks, the reported data shows the following average changes from that starting point: eye pressure measured two hours after taking the study drops was on average 3.73 mmHg lower than at the start; eye pressure measured just before taking the drops (the so-called "trough," meaning the point when the previous dose had been in the body the longest) was on average 3.22 mmHg lower; and eye pressure measured eight hours after taking the drops was on average 3.78 mmHg lower. In all cases, a lower number represents a reduction in eye pressure compared to baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00848536 · results posted 8 March 2011

    According to the results reported on ClinicalTrials.gov, this trial enrolled 371 people in total — 185 in one group and 186 in the other. The two groups were given different versions of the same eye drop: one called TRAVATAN APS and one called TRAVATAN. The trial was measuring the pressure inside participants' eyes (called intraocular pressure, or IOP — essentially how much fluid pressure is building up in the eye), taken at three different times of day: 9:00 am, 11:00 am, and 4:00 pm. The vast majority of participants completed the study — 181 in the TRAVATAN APS group and 179 in the TRAVATAN group. The reported data shows that eye pressure readings were very similar between the two groups at all three time points. At 9:00 am, the average eye pressure was 17.9 mmHg (millimetres of mercury, a standard unit for measuring pressure) in the TRAVATAN APS group and 18.1 mmHg in the TRAVATAN group. At 11:00 am, the figures were 17.4 mmHg and 17.5 mmHg respectively. At 4:00 pm, the reported averages were 16.9 mmHg for TRAVATAN APS and 17.1 mmHg for TRAVATAN. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00051168 · results posted 12 April 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 502 people, all of whom received the eye drop treatment called Travatan. Of those who started, 367 participants completed the trial, while 135 did not finish. The trial was measuring intraocular pressure — that is, the pressure inside the eye — which is commonly monitored in conditions like glaucoma. The reported data shows that the primary thing being measured was mean intraocular pressure (the average pressure inside the eye, measured in millimetres of mercury, or mmHg). According to the results reported on ClinicalTrials.gov, the average eye pressure recorded was 16.5 mmHg. This measurement was taken using a specialised instrument called a Goldmann applanation tonometer, which is a standard tool for checking eye pressure. No additional outcome measures beyond this single pressure reading appear to have been submitted in the structured results data. It is worth noting that the submitted results data does not include a baseline (starting) measurement to compare against, nor any secondary outcome results — so those figures are simply not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

See the full Glaucoma page · What changed recently

Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.