Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension Brinzolamide Brimonidine Intraocular pressure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1062
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

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