Status:
WITHDRAWN
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%
Lead Sponsor:
Alcon Research
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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%
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01452009
Start Date
November 1 2011
End Date
December 1 2011
Last Update
February 10 2012
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