Phase 3 Glaucoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give their consent freely and follow the study's requirements.
• Adults aged 18 or older, of any gender.
• People with a body mass index (BMI) of 18.50 or higher (a measure of body weight relative to height).
• People who have been diagnosed with chronic open-angle glaucoma or high eye pressure (ocular hypertension) in both eyes.
• People who need treatment in both eyes and whose doctor determines it is safe for them to stop or switch their current eye pressure medications for a set period before the trial begins.
• People who have completed the required "washout period" — a specific amount of time off their current eye pressure medications — before the trial's starting point.
• People whose eye pressure at the start of the trial (Day 0) measures at least 22 mmHg but less than 35 mmHg in each eye.
• People whose eye pressure, in the trial doctor's judgement, is likely to be manageable with just one medication.
• People with a baseline vision level of at least 20/100 (as measured on a standard vision chart) in each eye.
• Women who could potentially become pregnant must be using an accepted form of contraception, which includes: hormonal contraception (pill, injection, patch, or implant) used continuously for at least one month before starting the trial; an intrauterine device (IUD) or intrauterine system (IUS); a double barrier method (such as a condom used together with a cap or spermicide); a male partner who has had a vasectomy at least 6 months before screening; the woman having had surgical sterilisation (removal of both ovaries or tubal ligation) at least 6 weeks before the trial; or complete abstinence from sexual activity.
• People with no history of addiction to recreational drugs, drug dependence, or alcohol.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant.
• People who have a known allergy or medical reason they cannot use Bimatoprost or related medications, or any ingredients in the trial formulation.
• People with a current or past history of severe liver or kidney disease.
• People who have had a significant eye condition — such as corneal swelling, eye inflammation, eye infection, or eye injury — in either eye within the past 2 months (note: stable short-sightedness, squint, or cataracts may be acceptable at the trial doctor's discretion).
• People with current corneal (front-of-eye) abnormalities that would make accurate eye pressure measurement unreliable.
• People with visual field loss that the trial doctor considers to be functionally significant.
• People who have had a corneal transplant (corneal graft).
• People for whom pupil dilation is medically inadvisable.
• People who have ever had a corticosteroid implant placed inside the eye.
• People who have worn contact lenses within 1 week before the trial start date.
• People who have used eye drop corticosteroids or skin corticosteroids within 2 weeks before the trial start date.
• People who have used oral or systemic corticosteroids, or high-dose aspirin-type therapy (325 mg/day for 3 consecutive days), within 1 month before the trial start date.
• People who have had a corticosteroid injection into or around the eye within the past 6 months.
• People who have had any surgery inside the eye (such as cataract surgery) within the past 6 months.
• People who have had refractive surgery, filtering surgery, or laser surgery to reduce eye pressure (such as laser trabeculoplasty) within the past 12 months.
• People who have useful vision in only one eye (amblyopia with one sighted eye).
• People whose eye pressure was not controlled by Bimatoprost alone in the past.
• People who show significant signs of eye surface irritation or redness in either eye at examination.
• People with severe retinal disease or advanced glaucoma damage, including a cup-to-disc ratio greater than 0.8 (confirm with trial site) or split fixation.
• People taking systemic (whole-body) medications that may affect eye pressure, unless the dose has been stable for at least 3 months.
• People whose central corneal thickness measures less than 450 microns or greater than 650 microns (a measurement of the thickness of the front of the eye).
• People with any uncontrolled systemic (whole-body) health condition, such as uncontrolled heart disease, high blood pressure, diabetes, or liver problems.
• People who have had recurring seasonal eye allergies within the past 2 years.
• People with any other medical condition or serious illness that, in the trial doctor's opinion, makes participation inadvisable or would make it difficult to follow the study requirements.
• People who have participated in another clinical trial within the past 90 days before the trial's first dose.
• People with a confirmed history of Hepatitis B, Hepatitis C, or HIV infection.
• People who test positive on a urine pregnancy test.
• People with a confirmed COVID-19 infection.

Important: Always verify eligibility with the trial site directly before applying.