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A Long-term Safety Study of Once-daily Travatan

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: NCT00051168
Recruitment Status : Completed
First Posted : January 7, 2003
Results First Posted : April 12, 2010
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-angle Ocular Hypertension Drug: Travatan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Once-daily TRAVATAN
Study Start Date : January 2006
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: Travatan
Travoprost (0.004%)
 Drug: Travatan
Travoprost (0.004%) 1 drop each eye once daily


Outcome Measures
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Primary Outcome Measures :
  1. Mean Intraocular Pressure [ Time Frame: At 5 years. ]

    Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.

    All IOP measurements were performed with a Goldmann applanation tonometer.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Adult patients of any race and either sex with chronic angle-closure glaucoma.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051168


Locations
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United States, Texas
Europe
Fort Worth, Texas, United States
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00051168    
Other Study ID Numbers: C-02-20
First Posted: January 7, 2003    Key Record Dates
Results First Posted: April 12, 2010
Last Update Posted: October 7, 2011
Last Verified: April 2010
Keywords provided by Alcon Research:
Glaucoma
POAG
OAG
OHT
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
 Eye Diseases
Travoprost
Antihypertensive Agents