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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-angle Glaucoma

Intervention: Trabecular Meshwork Tissue Collection (Procedure); Travoprost 0.004% ophthalmic solution (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Theresa Landry, PhD, Study Director, Affiliation: Alcon Research

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).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Melanin Granule Count

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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;

- 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.

Locations and Contacts

Additional Information

Starting date: July 2004
Last updated: May 13, 2013

Page last updated: August 23, 2015

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