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

Last updated: February 9, 2012
Sponsor: Alcon Research
Overall Status: Trial Not Available

Phase

3

Condition

Glaucoma

Vascular Diseases

Stress

Treatment

N/A

Clinical Study ID

NCT01452009
C-10-151
  • Ages > 18
  • All Genders

Study 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

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 andpigment dispersion) or ocular hypertension

Exclusion

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 Snellenequivalent)

  7. Chronic, recurrent or severe inflammatory eye disease

  8. Clinically significant or progressive retinal disease

  9. Other ocular pathology

Study Design

Study Start date:
November 01, 2011
Estimated Completion Date:
December 31, 2011