Conditions: Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.

Detailed description:

Arms:
arm 1: 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. arm 2: 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.

Interventions: intervention 1: 0.1% brimonidine tartrate ophthalmic solution intervention 2: 0.01% bimatoprost ophthalmic solution intervention 3: 0.2% hypromellose lubricant eye drops intervention 4: latanoprost 0.005% ophthalmic solution
Intervention descriptions: intervention 1: 1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks. intervention 2: 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks. intervention 3: 1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks. intervention 4: 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Protocol document: