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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.
 
ClinicalTrials.gov Identifier: NCT00047554
Recruitment Status : Terminated (Study objectives met)
First Posted : October 18, 2002
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date October 8, 2002
First Posted Date October 18, 2002
Last Update Posted Date May 15, 2013
Study Start Date May 2003
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2013)
Change in Iris Pigmentation from Baseline for Study Eye by Visit [ Time Frame: Baseline, Up to Year 5 ]
As assessed by ocular photography
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2013)
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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of TRAVATAN in Subjects With Iris Pigmentation Changes
Official Title A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients were identified and enrolled from 23 investigational centers in the US.
Condition
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention Drug: Travoprost, 0.004% ophthalmic solution
Other Name: TRAVATAN®
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 13, 2013)
336
Original Enrollment Not Provided
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00047554
Other Study ID Numbers C-01-79
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alcon Research
Study Sponsor Alcon Research
Collaborators Not Provided
Investigators
Study Director: Theresa Landry, PhD Alcon Research
PRS Account Alcon Research
Verification Date May 2013