Study of TRAVATAN in Subjects With Iris Pigmentation Changes

NCT00047554 | Terminated

• 1 other identifier: C-01-79
• Study Type: observational
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

open-angle; glaucoma; ocular; hypertension; primary open-angle glaucoma; iris; pigmentation

Outcome Measures

Primary Outcomes (1)

• Change in Iris Pigmentation from Baseline for Study Eye by Visit

  As assessed by ocular photography

  Baseline, Up to Year 5

Secondary Outcomes (1)

• Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit

  Baseline, Up to Year 5

Study Arms (1)

TRAVATAN

Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years

Drug: Travoprost, 0.004% ophthalmic solution

Interventions

Travoprost, 0.004% ophthalmic solution DRUG

Also known as: TRAVATAN®

TRAVATAN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were identified and enrolled from 23 investigational centers in the US.

You may qualify if:

• Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
• Has experienced an iris pigmentation change while dosing with TRAVATAN;
• Currently dosing with TRAVATAN;

You may not qualify if:

• Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
• Not currently using TRAVATAN;
• Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
• History of any severe ocular pathology (including severe dry eye);

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Hypertension

Interventions

Travoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases; Vascular Diseases; Cardiovascular 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: October 8, 2002
• First Posted: October 18, 2002
• Study Start: May 1, 2003
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2013-05