Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle glaucoma Ocular Hypertension OAG OHT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 771
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components 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 3 study drug groups: Brinz/Brim, Brinz, or Brim.

Arms:
arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months arm 2: Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months arm 3: Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months

Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide 1% ophthalmic suspension intervention 3: Brimonidine tartrate 0.2% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: