glaucoma and increased pressure inside the eye
Conditions
Interventions
Dosage/Dose Regimen: Patients will receive one of 2 dose strengths of
Bimatoprost SR or Control treatment in the study eye on Day 1 (with repeat
administration of the same dose strength or Sham at W
Ocular Hypertension
Open-angle Glaucoma
Sponsors
Allergan Limited
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: • Written informed consent has been obtained • In the opinion of the investigator, based on prior use or on IOP rebound (elevation) during the washout period, patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs • The iridocorneal angle inferiorly in the study eye must be confirmed as being qualified by Reading Center AS-OCT assessment • By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment • Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, and both eyes require IOPlowering treatment (Note: diagnosis does not have to be the same in both eyes) • In the investigator's opinion, either eye can be treated adequately with topical ophthalmic beta-blocker (eg. timolol) eye drops as the sole therapy • In both eyes, at the baseline visit: Hour 0 IOP in the study eye of >= 22 mm Hg and = 19 mm Hg and
Exclusion criteria
Exclusion criteria: History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia, or complications (eg, a posterior capsular tear [with or without vitreous loss], iris trauma, etc) • In the investigator's opinion, patient is nonresponsive to topical ophthalmic beta-blockers and/or topical prostamides, prostaglandins, or prostaglandin analogs (eg, LUMIGAN, Xalatan, Travatan) • Contraindications to beta-blocker therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Measures Efficacy: Intraocular pressure (IOP) measured by Goldmann applanation tonometry Safety: Adverse events; ocular parameters as determined through assessment of visual acuity and visual field; evaluation of macroscopic bulbar conjunctival hyperemia and iris color; assessment of endothelial cell density and corneal thickness; IOP measurement, biomicroscopic and ophthalmoscopic examinations (including gonioscopy with Bimatoprost SR implant assessment, optic disc examination and dilated fundus examination); and optical coherence tomography (OCT) of the macula. | — |
Countries
Argentina, Canada, Colombia, Czechia, Egypt, Germany, Italy, Korea (the Republic of), Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Singapore, South Africa, Thailand, Turkey, United Kingdom, United States of America
Outcome results
None listed