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Study of TRAVATAN in Subjects With Iris Pigmentation Changes

This study has been terminated.
(Study objectives met)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00047554
First received: October 8, 2002
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

Drug Information available for: Travoprost
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
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
Other Name: TRAVATAN®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion:

  • 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.

Exclusion:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047554

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00047554     History of Changes
Other Study ID Numbers: C-01-79
Study First Received: October 8, 2002
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
open-angle
glaucoma
ocular
hypertension
 primary open-angle glaucoma
iris
pigmentation

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013