Phase
Condition
Ocular Hypertension
Glaucoma
Vascular Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative)or OHT in 1 or both eyes.
Participants must meet the following IOP requirements at Visit 3
mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
Participants with a best-corrected visual acuity (BCVA), using the Early Treatment ofDiabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalentof approximately 20/100) or better in either eye.
Exclusion
Exclusion Criteria:
Participants with known hypersensitivity or contraindications to latanoprost, NOtreatment, timolol maleate, other beta-adrenergic receptor antagonists or any of theingredients in the study drugs.
Participants with a central corneal thickness greater than 600 μm in either eye.
Participants with advanced glaucoma and participants with a cup/disc ratio greaterthan 0.8 or a history of split fixation, or a field loss threatening fixation ineither eye.
Participants who do not have an intact posterior capsule in either eye .
Participants with aphakia in either eye.
Participants with previous or active corneal disease in either eye.
Participants with current or a history of severe dry eye in either eye.
Participants with current or a history of optic disc hemorrhage in either eye.
Participants with current or a history of central/branch retinal vein or arteryocclusion in either eye.
Participants with current or a history of macular edema in either eye.
Participants with very narrow angles (3 quadrants with less than Grade 2 according toShaffer's anterior chamber angle grading system) and participants with angleclosure,congenital, and secondary glaucoma, and participants with history of angleclosure in either eye.
Participants with a diagnosis of a clinically significant or progressive retinaldisease in either eye.
Participants with any intraocular infection or inflammation in either eye within 3months(90 days) prior to Visit 1 (Screening).
Participants with a history of ocular laser surgery in either eye within the 3months(90 days) prior to Visit 1 (Screening).
Participants with a history of incisional ocular surgery or severe trauma in eithereye within 3 months (90 days) prior to Visit 1 (Screening).
Study Design
Connect with a study center
Bausch & Lomb Inc.
Rochester, New York 14609
United StatesSite Not Available
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