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

Terminated

• Conditions: Open-angle Glaucoma
• Interventions: Procedure: Trabecular Meshwork Tissue Collection; Drug: Travoprost 0.004% ophthalmic solution

• Registration Number: NCT01485822
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRAVATAN	Travoprost 0.004% ophthalmic solution	As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
TRAVATAN	Trabecular Meshwork Tissue Collection	As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
Treatment Naive	Trabecular Meshwork Tissue Collection	No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue

Primary Outcome Measures

Name	Time	Method
Melanin Granule Count	Day 1	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.