Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: AOG OHT Open-Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1001
Healthy volunteers: no

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

Detailed description:
This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.

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

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

Protocol document: