Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%
Phase 3
Withdrawn
- Conditions
- Open Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT01452009
- Lead Sponsor
- Alcon Research
- Brief Summary
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients 18 years of age or older
- Either gender
- Any race/ethnicity
- Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension
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Exclusion Criteria
- Patients with any form of glaucoma other than open-angle glaucoma.
- Patients with a central cornea thickness greater than 620 μm
- Patients with Shaffer angle Grade < 2
- Patients with a cup/disc ratio greater than 0.80
- Patients with severe central visual field loss
- Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
- Chronic, recurrent or severe inflammatory eye disease
- Clinically significant or progressive retinal disease
- Other ocular pathology
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Travoprost Ophthalmic Solution, 0.004% (New Formulation) Travoprost Ophthalmic Solution, 0.004% (New Formulation) - TRAVATAN® TRAVATAN® TRAVATAN® administered one drop once daily
- Primary Outcome Measures
Name Time Method Efficacy: mean IOP Efficacy as measured by mean IOP 3 months
- Secondary Outcome Measures
Name Time Method