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Phase IV Study of TRAVATAN 0.004% in Subjects With Iris Pigmentation Changes

This study is currently recruiting participants.
Verified by Alcon Research, August 2008

Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00047554
  Purpose

To monitor iris pigmentation changes over a five year period in subjects with open-angle glaucoma or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: TRAVATAN (travoprost ophthalmic solution) 0.004%
Phase IV

Genetics Home Reference related topics:   early-onset glaucoma   

MedlinePlus related topics:   Glaucoma    High Blood Pressure   

Drug Information available for:   Travoprost   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase IV Safety Study of TRAVATAN 0.004% in Subjects With TRAVATAN Induced Iris Pigmentation Changes C-01-79.

Further study details as provided by Alcon Research:

Study Start Date:   March 2007
Estimated Study Completion Date:   December 2013
Estimated Primary Completion Date:   December 2013 (Final data collection date for primary outcome measure)

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Subjects of any race and of either sex diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN and who are currently using TRAVATAN

  Contacts and Locations

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

Contacts
Contact: Alcon Call Center     1-888-451-EYES (3937)    

Locations
United States, Texas
Alcon Call Center For Locations     Recruiting
      Multiple Cities & Multiple States, Texas, United States

Sponsors and Collaborators
Alcon Research
  More Information


Responsible Party:   Alcon ( Jaime Dickerson )
Study ID Numbers:   C-01-79, C-01-79
First Received:   October 8, 2002
Last Updated:   August 4, 2008
ClinicalTrials.gov Identifier:   NCT00047554
Health Authority:   United States: Food and Drug Administration

Keywords provided by Alcon Research:
open-angle  
glaucoma  
ocular  
hypertension  
POAG
Iris
Pigmentation

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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