Conditions: Glaucoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

Detailed description:

Arms:
arm 1: 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. arm 2: 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Interventions: intervention 1: bimatoprost ophthalmic solution formulation A intervention 2: timolol ophthalmic solution intervention 3: bimatoprost vehicle
Intervention descriptions: intervention 1: 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks. intervention 2: 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. intervention 3: 1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.

Protocol document: