Travoprost 3-Month Safety and Efficacy Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost ophthalmic solution, 0.003%
* Drug: Travoprost ophthalmic solution, 0.004%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-Angle Glaucoma, Ocular Hypertension