At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 184 enrolled
Drug / intervention
Travoprost 0.004% PQ ophthalmic solution +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Travoprost 0.004% PQ ophthalmic solution, Timolol, 0.5% or 0.25% ophthalmic solution, and 1 other intervention for Pediatric Glaucoma and 2 related conditions. Completed, enrolled 184 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartSep 2012
Primary CompletionMar 2014
TodayJul 2026
First PostedJul 30, 2012
Enrollment StartSep 1, 2012
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.9 years ago
Interventions
Travoprost 0.004% PQ ophthalmic solutiondrug
Timolol, 0.5% or 0.25% ophthalmic solutiondrug
Patients 2 months to \< 3 years of age received 0.25%
Travoprost Vehicledrug
Inactive ingredients used to maintain masking