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

NCT01485822 | Terminated

• 1 other identifier: C-01-78
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

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

Keywords

Glaucoma; Travatan; Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TRAVATAN

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

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

Treatment Naive

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

Procedure: Trabecular Meshwork Tissue Collection

Interventions

Trabecular Meshwork Tissue Collection 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.

TRAVATAN; Treatment Naive

Travoprost 0.004% ophthalmic solution DRUG

Also known as: TRAVATAN Z, TRAVATAN

TRAVATAN

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Travoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Theresa Landry, PhD

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 6, 2011
• Study Start: July 1, 2004
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05