Back to resultsA Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004%/timolol 0.5% ophthalmic solution
Travoprost ophthalmic solution, 0.004%
Timolol maleate ophthalmic solution, 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open-angle glaucoma or ocular hypertension
Eligibility Criteria
Inclusion Criteria:
- Adult patients with open-angle glaucoma or ocular hypertension;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Visual acuity worse than 0.60;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Seattle
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DuoTrav
Travatan/Timolol
Arm Description
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid
One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.
Outcomes
Primary Outcome Measures
Patient compliance
Patient compliance will be measured with a dosing aid that records time and date of study drug administration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465803
Brief Title
A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
Official Title
Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus 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
Open-angle Glaucoma, Ocular Hypertension
Keywords
Open-angle glaucoma or ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DuoTrav
Arm Type
Other
Arm Description
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid
Arm Title
Travatan/Timolol
Arm Type
Other
Arm Description
One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/timolol 0.5% ophthalmic solution
Other Intervention Name(s)
DuoTrav
Intervention Description
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.004%
Other Intervention Name(s)
TRAVATAN
Intervention Description
One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
Intervention Type
Drug
Intervention Name(s)
Timolol maleate ophthalmic solution, 0.5%
Intervention Description
One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid
Primary Outcome Measure Information:
Title
Patient compliance
Description
Patient compliance will be measured with a dosing aid that records time and date of study drug administration
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with open-angle glaucoma or ocular hypertension;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Visual acuity worse than 0.60;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
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