Official Title: “A Phase IV Safety Study of TRAVATAN 0.004% in Subjects With TRAVATAN Induced Iris Pigmentation Changes C-01-79.”

To monitor iris pigmentation changes over a five year period in subjects with open-angle glaucoma or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Study Primary Completion Date: December 2013

Intervention(s) in this Clinical Trial

• Drug: Travatan 0.004%
  • Travatan 0.004% 1 drop QD

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Travatan 0.004%
  • Travatan 0.004% Opthalmic Suspension 1 drop QD

Primary Measures

• Iris photography
  • Time Frame: Every 6 months for first 2 years, then yearly
    Safety Issue?: Yes

• Subjects of any race and of either sex diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN and who are currently using TRAVATAN

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00047554

Study ID Number: C-01-79

ClinicalTrials.gov Identifier: NCT00047554

Health Authority: United States: Food and Drug Administration