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A Long-term Safety Study of Once-daily Travatan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00051168
First received: January 3, 2003
Last updated: October 2, 2011
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Once-daily TRAVATAN

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure [ Time Frame: At 5 years. ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Adult patients of any race and either sex with chronic angle-closure glaucoma.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051168

Locations
United States, Texas
Europe
Fort Worth, Texas, United States
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00051168     History of Changes
Other Study ID Numbers: C-02-20
Study First Received: January 3, 2003
Results First Received: March 22, 2010
Last Updated: October 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
POAG
OAG
OHT

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013