NCT00047554

Terminated

Study of TRAVATAN in Subjects With Iris Pigmentation Changes

Alcon Research Source

Alcon Research

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

C-01-79

Study Type

observational

Actual enrollment (reported)

336

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2012

Actual (reported)

Study Completion

June 2012

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 336 participants
Study completion date: June 2012
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 8, 2002
Actual (reported)
First Posted
October 18, 2002
Actual (reported)
Study Start
May 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)
Study Completion
June 2012
Actual (reported)

Last Updated: May 15, 2013
Status Verified: May 2013
Last Update Submitted: May 13, 2013

Conditions

Open-Angle Glaucoma Ocular Hypertension

Keywords

open-angleglaucomaocularhypertensionprimary open-angle glaucomairispigmentation

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 solutionDrug

Also known as: TRAVATAN®

TRAVATAN

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

Alcon Research
Industrylead

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucomaHypertension

Interventions

TravoprostOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandins

Study Officials

Theresa Landry, PhD
Alcon Research
STUDY DIRECTOR

Enrollment

336 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

NCT02914509

Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

Phase 3Completed

NCT00293761

A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Phase 3Completed

NCT07400926

Observational Trial of the Updated Inserter for the Travoprost Intracameral Implant 75mcg

Recruiting

NCT01298687

Divided Dose of TRAVATAN®

Phase 2Completed

NCT00471068

Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Phase 4Terminated

NCT01452009

Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Phase 3Withdrawn

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);

Contact the study team to confirm eligibility.

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

Primary Completion

June 2012

Actual (reported)

Study Completion

June 2012

Actual (reported)

Last Updated

May 15, 2013

Record last verified: 2013-05

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00047554
Data provider: ClinicalTrials.gov
Source updated: 2013-05-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:16 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

TRAVATAN

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record