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

NCT ID: NCT01485822

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2012-02-29

Brief Summary

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).

Conditions

Open-angle Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TRAVATAN

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

Trabecular Meshwork Tissue Collection

Intervention Type: PROCEDURE

A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Treatment Naive

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

Trabecular Meshwork Tissue Collection

Intervention Type: PROCEDURE

A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.

Interventions

Trabecular Meshwork Tissue Collection

A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.

Intervention Type: PROCEDURE

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

TRAVATAN Z; TRAVATAN

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Landry, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-01-78

Identifier Type: -

Identifier Source: org_study_id