Back to resultsA Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
Timolol 5 mg/ml eye drops, solution
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Diagnosis of open-angle glaucoma Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Pregnant Other protocol-defined exclusion criteria may apply
Sites / Locations
- United States Investigative Sites
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Brinzolamide +Timolol
Brinzolamide
Timolol
Arm Description
Outcomes
Primary Outcome Measures
Mean intra-ocular pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314158
Brief Title
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
523 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brinzolamide +Timolol
Arm Type
Experimental
Arm Title
Brinzolamide
Arm Type
Active Comparator
Arm Title
Timolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
Intervention Description
One drop twice daily in each study eye for six months
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension
Other Intervention Name(s)
AZOPT
Intervention Description
One drop twice daily in each study eye for six months
Intervention Type
Drug
Intervention Name(s)
Timolol 5 mg/ml eye drops, solution
Intervention Description
One drop twice daily in each study eye for six months
Primary Outcome Measure Information:
Title
Mean intra-ocular pressure (IOP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Diagnosis of open-angle glaucoma
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Under 18
Pregnant
Other protocol-defined exclusion criteria may apply
Facility Information:
Facility Name
United States Investigative Sites
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18538406
Citation
Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.
Results Reference
result
Learn more about this trial
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
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