Travoprost 3-Month Safety and Efficacy Study

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost ophthalmic solution, 0.003%; Drug: Travoprost ophthalmic solution, 0.004%

• Registration Number: NCT01453855
• Lead Sponsor: Alcon Research

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Study Start: 2011-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-08
• Results First Submitted: 2013-08-13
• Results First Submitted QC: 2013-08-13
• Last Update Submitted: 2013-08-13
• Results First Posted: 2013-10-18
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1099

Inclusion Criteria

• Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
• Qualifying intraocular pressure at both eligibility visits.
• Understand and sign an informed consent form.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
• Severe central visual field loss in either eye.
• Chronic, recurrent or severe inflammatory eye disease.
• Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
• Any abnormality preventing reliable applanation tonometry.
• Hypersensitivity to prostaglandin analogs or to any component of the study medications.
• Therapy with another investigational agent within 30 days prior to the Screening Visit.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost 0.003%	Travoprost ophthalmic solution, 0.003%	Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
TRAVATAN	Travoprost ophthalmic solution, 0.004%	Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)	Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)	As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).