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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost ophthalmic solution, 0.004%; Drug: Travoprost ophthalmic solution, 0.003%

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).

• Study Type: Interventional
• Enrollment (Actual): 1099
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travoprost 0.003%; Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	Drug: Travoprost ophthalmic solution, 0.003%
Active Comparator: TRAVATAN; Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months	Drug: Travoprost ophthalmic solution, 0.004%; Other Names: TRAVATAN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 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).	Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Theresa A Landry, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Open-Angle Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-11-034; 2011-004587-29 (EudraCT Number)