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

Alcon Research88 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Open-angle Glaucoma

Interventions

Trabecular Meshwork Tissue CollectionPROCEDURE

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 solutionDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Data from ClinicalTrials.gov

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