Back to resultsIOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Travoprost/brinzolamide
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open-angle glaucoma, ocular hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension
Exclusion Criteria:
- Age (Under 18)
Sites / Locations
- Artesia
Outcomes
Primary Outcome Measures
Mean IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00527501
Brief Title
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
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 compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID 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, ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Travoprost/brinzolamide
Primary Outcome Measure Information:
Title
Mean IOP
Time Frame
Time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension
Exclusion Criteria:
Age (Under 18)
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
Artesia
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
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