Conditions: Pediatric Glaucoma Elevated IOP in Pediatric Patients Ocular Hypertension in Pediatric Patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 184
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.

Detailed description:

Arms:
arm 1: Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months arm 2: Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months

Interventions: intervention 1: Travoprost 0.004% PQ ophthalmic solution intervention 2: Timolol, 0.5% or 0.25% ophthalmic solution intervention 3: Travoprost Vehicle
Intervention descriptions: intervention 1: None intervention 2: Patients 2 months to \< 3 years of age received 0.25% intervention 3: Inactive ingredients used to maintain masking

Protocol document: