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

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).

Study Overview

• Status: Terminated
• Conditions: Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004% ophthalmic solution; Procedure: Trabecular Meshwork Tissue Collection

• Study Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TRAVATAN; As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years	Drug: Travoprost 0.004% ophthalmic solution; Other Names: TRAVATAN; TRAVATAN Z; Procedure: 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.
Treatment Naive; No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melanin Granule Count	A trabecular meshwork tissue sample was collected by the investigator. The number of pigment granules was counted for three separate microscopic fields of view. Mean melanin granule count was calculated.	Day 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Theresa Landry, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Glaucoma; Trabeculectomy; Travatan
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Travoprost
• Other Study ID Numbers: C-01-78