Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Terminated

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: Travoprost, 0.004% ophthalmic solution

• Registration Number: NCT00047554
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-10-08
• Study First Submitted QC: 2002-10-17
• Study First Posted: 2002-10-18
• Study Start: 2003-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRAVATAN	Travoprost, 0.004% ophthalmic solution	Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years

Primary Outcome Measures

Name	Time	Method
Change in Iris Pigmentation from Baseline for Study Eye by Visit	Baseline, Up to Year 5	As assessed by ocular photography

Secondary Outcome Measures

Name	Time	Method
Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit	Baseline, Up to Year 5	As assessed by ocular photography