Back to resultsA Long-term Safety Study of Once-daily Travatan
Primary Purpose
Glaucoma, Open-angle, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Travatan
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-angle focused on measuring Glaucoma, POAG, OAG, OHT
Eligibility Criteria
Adult patients of any race and either sex with chronic angle-closure glaucoma.
Sites / Locations
- Europe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Travatan
Arm Description
Travoprost (0.004%)
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051168
Brief Title
A Long-term Safety Study of Once-daily Travatan
Official Title
A Long-term Safety Study of Once-daily TRAVATAN
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-angle, Ocular Hypertension
Keywords
Glaucoma, POAG, OAG, OHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
502 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travatan
Arm Type
Experimental
Arm Description
Travoprost (0.004%)
Intervention Type
Drug
Intervention Name(s)
Travatan
Intervention Description
Travoprost (0.004%) 1 drop each eye once daily
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure
Description
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.
Time Frame
At 5 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients of any race and either sex with chronic angle-closure glaucoma.
Facility Information:
Facility Name
Europe
City
Fort Worth
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Long-term Safety Study of Once-daily Travatan
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