DuoTrav® Eye Drops As Replacement Therapy Program
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DuoTrav
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Glaucoma, IOP, DuoTrav
Eligibility Criteria
Inclusion Criteria:
- Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction
Exclusion Criteria:
- None
Sites / Locations
- Contact Alcon for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
DuoTrav
Outcomes
Primary Outcome Measures
Intra Ocular Pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00828906
Brief Title
DuoTrav® Eye Drops As Replacement Therapy Program
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 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
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).
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
Glaucoma, IOP, DuoTrav
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
DuoTrav
Intervention Type
Drug
Intervention Name(s)
DuoTrav
Intervention Description
DuoTrav Eye Drops
Primary Outcome Measure Information:
Title
Intra Ocular Pressure
Time Frame
visit 1, Visits 2-3, Visits 6-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with OAG or OH for whom single agent therapy provides insufficient intraocular pressure reduction
Exclusion Criteria:
None
Facility Information:
Facility Name
Contact Alcon for Trial Locations
City
Bejing
Country
China
12. IPD Sharing Statement
Learn more about this trial
DuoTrav® Eye Drops As Replacement Therapy Program
We'll reach out to this number within 24 hrs