Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: open-angle glaucoma ocular hypertension OAG OHT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1184
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.

Detailed description:
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.

Arms:
arm 1: Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. arm 2: Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.

Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension intervention 2: Vehicle intervention 3: Brinzolamide 1% ophthalmic suspension intervention 4: Brimonidine tartrate 0.2% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo for masking purposes intervention 3: None intervention 4: None

Protocol document: