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
  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:


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
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, see Learn About Clinical Studies.

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 July 23, 2014