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

October 8, 2002
May 13, 2013
May 2003
June 2012   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00047554 on ClinicalTrials.gov Archive Site
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
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Study of TRAVATAN in Subjects With Iris Pigmentation Changes
A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Open-Angle Glaucoma
  • Ocular Hypertension
Drug: Travoprost, 0.004% ophthalmic solution
Other Name: TRAVATAN®
TRAVATAN
Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years
Intervention: Drug: Travoprost, 0.004% ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
336
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00047554
C-01-79
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry, PhD Alcon Research
Alcon Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP