Conditions: Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

Brief summary:
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Detailed description:

Arms:
arm 1: Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) arm 2: Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)

Interventions: intervention 1: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% intervention 2: timolol maleate 0.5% intervention 3: latanoprost 0.005%
Intervention descriptions: intervention 1: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 2: 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 3: 1 drop of latanoprost 0.005% once nightly.

Protocol document: