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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
  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:


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
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 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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014