Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TRAVATAN

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

Travoprost, 0.004% ophthalmic solution

Intervention Type DRUG

Interventions

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Travoprost, 0.004% ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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TRAVATAN®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
* Has experienced an iris pigmentation change while dosing with TRAVATAN;
* Currently dosing with TRAVATAN;

Exclusion:

* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
* Not currently using TRAVATAN;
* Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
* History of any severe ocular pathology (including severe dry eye);

Eligible Sex

ALL

Accepts Healthy Volunteers

No