Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

NCT02003391 ↗

Phase 4 Completed 157 enrolled Alcon Research

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

Timeline

Start: 2013-12
Primary completion: 2015-05
Completion: 2015-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); DuoTrav vs Beta-blocker; p <0.0001; Mean Difference (Final Values) -4.6191; ANCOVA NCT02003391 ↗

paper (-4.6 mmHg; one-sided 95% confidence interval [-inf, -3.9]; p < 0.0001 [primary endpoint]); PMID 28239491 ↗

Publications

Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Timolol	Other / unclassified	0.5 %	Topical
Subject	Travoprost	Other / unclassified	0.004 %	Topical