Phase IV Study of TRAVATAN 0.004% in Subjects With Iris Pigmentation Changes
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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- Iris photography
- Time Frame: Every 6 months for first 2 years, then yearly
Safety Issue?: Yes
- Time Frame: Every 6 months for first 2 years, then yearly
Criteria for Participation in this Clinical Trial
- 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
Clinical Trial Investigator Information
Lead Investigator: Alcon Research Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00047554
