A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

Alcon

Status: Terminated

Conditions: Open-angle Glaucoma

Treatments: Drug: Travoprost 0.004% ophthalmic solution; Procedure: Trabecular Meshwork Tissue Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01485822

C-01-78

Details and patient eligibility

About

The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).

Enrollment: 88 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
• Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
• Requires a trabeculectomy;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Pseudoexfoliation or pigment dispersion;
• History of chronic or recurrent severe inflammatory eye disease;
• History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
• Greater than one month but less than two years of exposure to TRAVATAN;
• Pregnant, breast-feeding, not using highly effective birth control;
• Other protocol-defined exclusion criteria may apply.

Trial design

88 participants in 2 patient groups

TRAVATAN

Description:

As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years

Treatment:

Procedure: Trabecular Meshwork Tissue Collection

Drug: Travoprost 0.004% ophthalmic solution

Treatment Naive

Description:

No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue

Treatment:

Procedure: Trabecular Meshwork Tissue Collection