Conditions: Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Detailed description:

Arms:
arm 1: One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. arm 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Interventions: intervention 1: brimonidine tartrate/timolol fixed combination ophthalmic solution intervention 2: brimonidine tartrate ophthalmic solution intervention 3: timolol ophthalmic solution intervention 4: fixed combination vehicle
Intervention descriptions: intervention 1: One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 3: One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 4: Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Protocol document: