Travoprost 3-Month Safety and Efficacy Study

Alcon Research1,099 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,099

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Travoprost ophthalmic solution, 0.003%DRUG

Travoprost ophthalmic solution, 0.004%DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

Data from ClinicalTrials.gov

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