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

Study Overview
=================
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).

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

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Procedure: Trabecular Meshwork Tissue Collection
* Drug: Travoprost 0.004% ophthalmic solution


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TRAVATAN<br>As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years | Procedure: Trabecular Meshwork Tissue Collection<br>* 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.<br>Drug: Travoprost 0.004% ophthalmic solution<br> <br> * Other names: TRAVATAN;|
| Treatment Naive<br>No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue | Procedure: Trabecular Meshwork Tissue Collection<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Travatan, Trabeculectomy