Conditions: Glaucoma, Open-Angle Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 185
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms:
arm 1: Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months. arm 2: Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Interventions: intervention 1: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) intervention 2: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Intervention descriptions: intervention 1: One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months. intervention 2: One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Protocol document: