NCT01453855

Travoprost 3-Month Safety and Efficacy Study

A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,099 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Detailed description

This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Travoprost ophthalmic solution, 0.003%
DRUG	Travoprost ophthalmic solution, 0.004%

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-10-18
• Last updated: 2013-10-18
• Results posted: 2013-10-18