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A Long-term Safety Study of Once-daily Travatan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00051168
First Posted: January 7, 2003
Last Update Posted: October 7, 2011
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Glaucoma, Open-angle Ocular Hypertension Drug: Travatan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.



Enrollment: 502
Study Start Date: January 2006
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travatan
Travoprost (0.004%)
Drug: Travatan
Travoprost (0.004%) 1 drop each eye once daily

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Texas
Europe
Fort Worth, Texas, United States
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00051168     History of Changes
Other Study ID Numbers: C-02-20
First Submitted: January 3, 2003
First Posted: January 7, 2003
Results First Submitted: March 22, 2010
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:
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases
Travoprost
Antihypertensive Agents