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A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
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.
Details
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 184 |
| Start date | 2012-09 |
| Completion | 2014-03 |
Conditions
- Pediatric Glaucoma
- Elevated IOP in Pediatric Patients
- Ocular Hypertension in Pediatric Patients
Interventions
- Travoprost 0.004% PQ ophthalmic solution
- Timolol, 0.5% or 0.25% ophthalmic solution
- Travoprost Vehicle
Primary outcomes
- Mean Change From Baseline in IOP at Month 3 — Baseline (Day 0), Month 3
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.