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

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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%

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

Criteria

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