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

Open-angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01485822
• Other study ID #: C-01-78
• Status: Terminated
• Phase: Phase 4
• First received: December 1, 2011
• Last updated: May 13, 2013
• Start date: July 2004
• Est. completion date: February 2012

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Procedure:
• Trabecular 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.

Drug:
• Travoprost 0.004% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes