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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01485822

Enrollment

Registered

2011-12-06

Start date

2004-07-31

Completion date

2012-02-29

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Keywords

Glaucoma, Travatan, Trabeculectomy

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).

Interventions

PROCEDURETrabecular Meshwork Tissue Collection

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.

DRUGTravoprost 0.004% ophthalmic solution

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026