Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: OAG OHT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 493
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the fixed combination (BID) \[Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension\] to the unfixed combination (BID) \[Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution\] with respect to intraocular pressure (IOP)-lowering efficacy.

Detailed description:
This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.

Arms:
arm 1: Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months arm 2: Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months

Interventions: intervention 1: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension intervention 2: Brinzolamide 10 mg/mL eye drops, suspension intervention 3: Brimonidine 2 mg/mL eye drops, solution intervention 4: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used as a placebo for masking purposes

Protocol document: