CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 135 enrolled
Drug / intervention
travoprost ophthalmic solution 0.004% +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.

Search/NCT01547598
NCT01547598Phase 4Completed
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Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

Allergan·interventional·Posted Mar 8, 2012·Updated Aug 15, 2014

In Brief

A Phase 4 clinical trial evaluating travoprost ophthalmic solution 0.004%, travoprost 0.004% / timolol 0.5% combination ophthalmic solution, and 1 other intervention for Glaucoma, Open-Angle and Ocular Hypertension. Completed, enrolled 135 participants across 1 site.

Detailed Summary

This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open-Angle, Ocular Hypertension
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.3 years ago

Interventions

travoprost ophthalmic solution 0.004%drug

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.

travoprost 0.004% / timolol 0.5% combination ophthalmic solutiondrug

DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Bimatoprost ophthalmic solution 0.01%drug

LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.