Conditions: Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Detailed description:

Arms:
arm 1: One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. arm 2: One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. arm 3: One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Interventions: intervention 1: Fixed-Combination Bimatoprost/Brimonidine intervention 2: Bimatoprost Ophthalmic Solution 0.01% intervention 3: Vehicle Ophthalmic Solution intervention 4: Brimonidine Tartrate Ophthalmic Solution 0.2%
Intervention descriptions: intervention 1: One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. intervention 2: One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks. intervention 3: One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. intervention 4: One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Protocol document: