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Study of TRAVATAN in Subjects With Iris Pigmentation Changes

This study has been terminated.
(Study objectives met)
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: October 8, 2002
Last updated: May 13, 2013
Last verified: May 2013
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 Intervention Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost, 0.004% ophthalmic solution Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 336
Study Start Date: May 2003
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®


Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00047554

Sponsors and Collaborators
Alcon Research
Study Director: Theresa Landry, PhD Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00047554     History of Changes
Other Study ID Numbers: C-01-79
Study First Received: October 8, 2002
Last Updated: May 13, 2013

Keywords provided by Alcon Research:
primary open-angle glaucoma

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents processed this record on September 25, 2017