Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Phase 3WithdrawnNCT01452009

Alcon Research

Overview

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

Travoprost Ophthalmic Solution, 0.004% (New Formulation)DRUG

Travoprost Ophthalmic Solution, 0.004% given one drop once daily

TRAVATAN®DRUG

TRAVATAN® administered one drop once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients 18 years of age or older 2. Either gender 3. Any race/ethnicity 4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension Exclusion Criteria: 1. Patients with any form of glaucoma other than open-angle glaucoma. 2. Patients with a central cornea thickness greater than 620 μm 3. Patients with Shaffer angle Grade \< 2 4. Patients with a cup/disc ratio greater than 0.80 5. Patients with severe central visual field loss 6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent) 7. Chronic, recurrent or severe inflammatory eye disease 8. Clinically significant or progressive retinal disease 9. Other ocular pathology

Outcomes

Primary Outcomes

Efficacy: mean IOP Efficacy as measured by mean IOP

Time frame: 3 months

Data from ClinicalTrials.gov

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