Phase 1 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 years or older (male or female)
• 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 are able to stop or switch their current eye pressure medications for a required period before the study begins
• People whose eye pressure medications have been stopped or adjusted for a sufficient period before the study starts, as directed by the study doctor
• People whose eye pressure at the start of the study measures between 22 and 28 mmHg in each eye, with no more than 5 mmHg difference between the two eyes
• People whose eye pressure, in the study doctor's judgment, is likely to be managed with a single medication
• People with a vision level of at least 20/100 (corrected with glasses or lenses) in each eye
• Women who could become pregnant and who are using an acceptable and reliable method of contraception, such as hormonal contraception (pill, patch, injection, or implant) used for at least one month before the study starts; an intrauterine device (IUD) or similar device; a double barrier method (e.g., condom plus diaphragm or spermicide); a partner who has had a vasectomy at least 6 months prior; surgical sterilisation of the woman at least 6 weeks prior; or complete abstinence from sex
• 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 only recently been diagnosed with open-angle glaucoma or high eye pressure and have never been treated for it before
• People who have a known allergy or medical reason to avoid bimatoprost or related medications, or any ingredient in the study formulation
• People with a current or past history of serious 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 2 months before the study starts (note: stable short-sightedness, a turned eye, or cataracts may be acceptable at the study doctor's discretion)
• People with corneal abnormalities that would prevent accurate eye pressure measurement using standard equipment
• People with significant loss of visual field, as judged by the study doctor
• People who have had a corneal graft (transplant)
• People for whom pupil dilation is not medically appropriate
• People who have ever had a corticosteroid implant placed inside the eye
• People who have worn contact lenses within 1 week before the study starts
• People who have used corticosteroid eye drops or skin/body corticosteroid treatments within 2 weeks before the study starts
• People who have used systemic (whole-body) corticosteroids or high-dose aspirin-type therapy (325 mg/day for 3 consecutive days) within 1 month before the study starts
• People who have received a corticosteroid injection into or around the eye within 6 months before the study starts
• People who have had eye surgery (other than those listed separately) within 6 months before the study starts
• People who have had refractive surgery, glaucoma filtering surgery, or laser treatment to reduce eye pressure within 12 months before the study starts
• People who have vision in only one eye
• People whose eye pressure was not controlled by bimatoprost alone in the past
• People with noticeable eye surface problems, such as redness or irritation, found during an eye examination
• People with severe retinal disease or serious eye damage, including advanced glaucoma damage as determined by specific measurements, as judged by the study doctor
• People who are taking certain systemic medications that may affect eye pressure and whose dose has not been stable for at least 3 months
• People whose central corneal thickness measurement is less than 450 or greater than 650 microns
• People with a known uncontrolled systemic 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 that the study doctor believes could make participation unsafe or difficult
• People who have taken part in another clinical trial within 30 days before the study starts
• People with a known history of Hepatitis B, Hepatitis C, or HIV infection
• People with a positive pregnancy test at the start of the study

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