Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Alcon Research336 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

336

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Travoprost, 0.004% ophthalmic solutionDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion: * 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; * Other protocol-defined inclusion criteria may apply. 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); * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Change in Iris Pigmentation from Baseline for Study Eye by Visit

As assessed by ocular photography

Time frame: Baseline, Up to Year 5

Secondary Outcomes

Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit

As assessed by ocular photography

Time frame: Baseline, Up to Year 5

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.