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Study of TRAVATAN in Subjects With Iris Pigmentation Changes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047554
Recruitment Status : Terminated (Study objectives met)
First Posted : October 18, 2002
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost, 0.004% ophthalmic solution

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Study Type : Observational
Actual Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
Study Start Date : May 2003
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Group/Cohort Intervention/treatment
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
Other Name: TRAVATAN®

Primary Outcome Measures :
  1. Change in Iris Pigmentation from Baseline for Study Eye by Visit [ Time Frame: Baseline, Up to Year 5 ]
    As assessed by ocular photography

Secondary Outcome Measures :
  1. Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit [ Time Frame: Baseline, Up to Year 5 ]
    As assessed by ocular photography

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were identified and enrolled from 23 investigational centers in the US.


  • 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;
  • Other protocol-defined inclusion criteria may apply.


  • 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);
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047554

Sponsors and Collaborators
Alcon Research
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Study Director: Theresa Landry, PhD Alcon Research
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Responsible Party: Alcon Research Identifier: NCT00047554    
Other Study ID Numbers: C-01-79
First Posted: October 18, 2002    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by Alcon Research:
primary open-angle glaucoma
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents