Trial 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
According to the results reported on ClinicalTrials.gov, this trial involved 26 people in total — 14 assigned to use a newer device called the Mk II Inserter and 12 assigned to use an older version called the Mk I Inserter. One person from each group did not complete the trial. The study was looking at a small implant placed into the eye (called a fluocinolone acetonide insert, or FAI insert) and comparing how easy it was for doctors to use each version of the inserter device, as well as tracking certain eye-related events over 12 months. The reported data shows that for the primary measurement — whether the insertion procedure was rated by the doctor as satisfactory (meaning "Very Easy," "Easy," or "Routine") — 10 eyes in the Mk II group and 3 eyes in the Mk I group received a satisfactory rating. The reported data also shows that 3 eyes in the Mk II group and 2 eyes in the Mk I group fell into another rating category, with further breakdowns across additional rating levels. For the secondary measurement, which tracked specific eye-related events over 12 months, the reported data shows that 12 eyes in the Mk II group and 7 in the Mk I group were noted in one category, 1 eye in each group in another, 10 eyes in the Mk II group and 4 in the Mk I group in a further category, and no eyes in either group in two other categories. One eye in the Mk I group was noted in a remaining category, and none in the Mk II group. Detailed labels for each of these specific categories were not 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 full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Uveitis Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are male or a non-pregnant female aged 18 or older at the time of signing the consent form
- At least one of your eyes has a history of non-infectious uveitis (inflammation inside the eye not caused by infection) that affected the back part of the eye
- You are able to understand and sign the consent form
- You are willing and able to follow the study requirements throughout the trial
Who may not be able to join:
- You have a known allergy to the drug fluocinolone acetonide or any ingredient in the study implant (confirm with trial site)
- You have or have had a cancer affecting either eye, including a type called choroidal melanoma
- Your eye inflammation (uveitis) is caused by an infection
- You currently have a viral infection affecting the front surface of your eye, such as certain forms of herpes, vaccinia, or chickenpox-related eye infections
- You currently have a bacterial infection called tuberculosis or a fungal infection affecting your eye
- A test done during screening shows you are positive for HIV or syphilis
- You have had a general body infection within the 30 days before the study starts
- You have a detached retina in the area where the study implant would be placed
- The pressure inside your eye is too high (above 21 mmHg) or too low (below 6 mmHg)
- You are currently using eye drops or other medicines to lower the pressure in your study eye
- You have been diagnosed with glaucoma or high eye pressure in your study eye, unless a previous surgery has brought your eye pressure into the normal range and kept it stable there
- You have a known history of your eye pressure rising significantly in response to steroid treatment, unless a previous surgery has brought your eye pressure into the normal range and kept it stable there
- You have had eye surgery or a certain laser procedure on the study eye within the 30 days before the study starts
- You have received certain previous treatments injected into or around the study eye within specific time periods before the study starts (confirm exact timeframes with trial site)
- You have received a steroid injection around or near the study eye within the 30 days before the study starts
- You have taken part in another clinical trial using an experimental drug or device within the 30 days before the study starts
- You are currently pregnant or breastfeeding, or you are able to become pregnant but are unwilling or unable to use an approved form of contraception from at least 14 days before the study starts until the 12-month visit
- The study doctor believes for any reason that joining this trial would not be appropriate for you
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.