Back to resultsIOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Azopt
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Glaucoma
Exclusion Criteria:
- Under 18
Sites / Locations
- Sydney Study Site
Outcomes
Primary Outcome Measures
IOP lowering
Secondary Outcome Measures
safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382226
Brief Title
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Official Title
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azopt
Primary Outcome Measure Information:
Title
IOP lowering
Secondary Outcome Measure Information:
Title
safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glaucoma
Exclusion Criteria:
Under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jasek
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Sydney Study Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
21048504
Citation
Goldberg I, Crowston JG, Jasek MC, Stewart JA, Stewart WC; ADAPT Study Investigator Group. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012 Jan;21(1):55-9. doi: 10.1097/IJG.0b013e3181fc8142.
Results Reference
result
Learn more about this trial
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
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