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
Study Type
Interventional
Intervention
Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
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: 18 years or older Diagnosis of open-angle glaucoma or ocular hypertension Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 Pregnant Other protocol-defined exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brinzolamide + Timolol
Dorzolamide + Timolol
Arm Description
Outcomes
Primary Outcome Measures
Mean IOP
Secondary Outcome Measures
Percent patients with IOP < 18 mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314171
Brief Title
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official 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
October 2005 (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
Data Monitoring Committee
No
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
Keywords
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
437 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brinzolamide + Timolol
Arm Type
Experimental
Arm Title
Dorzolamide + 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 in the study eye(s) twice daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
Other Intervention Name(s)
COSOPT
Intervention Description
One drop in the study eye(s) twice daily for 12 months
Primary Outcome Measure Information:
Title
Mean IOP
Secondary Outcome Measure Information:
Title
Percent patients with IOP < 18 mmHg
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Diagnosis of open-angle glaucoma or ocular hypertension
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Under 18
Pregnant
Other protocol-defined exclusion criteria may apply
12. IPD Sharing Statement
Citations:
PubMed Identifier
19365194
Citation
Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.
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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