Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Alcon

Status: Terminated

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost, 0.004% ophthalmic solution

Study type: Observational

Funder types: Industry

Identifiers

NCT00047554

C-01-79

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

336 participants in 1 patient group

TRAVATAN

Description:

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

Treatment:

Drug: Travoprost, 0.004% ophthalmic solution