Back to resultsAn Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
latanoprost 0.005%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age;
- Give written informed consent;
- Be in good general health as determined by your doctor;
- Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
- If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
- Understand the study instructions, and be able to follow the study instructions; and
- Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.
Exclusion Criteria:
- Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
- Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
- Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Latanoprost 0.005% ophthalmic solution
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) at Week 12
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811564
Brief Title
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Arm Title
2
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
Other Intervention Name(s)
Combigan™
Intervention Description
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005%
Other Intervention Name(s)
Xalatan™
Intervention Description
1 drop of study medication taken once daily
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at Week 12
Description
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.
Exclusion Criteria:
Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Slingerlands
State/Province
New York
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22458918
Citation
Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.
Results Reference
derived
Learn more about this trial
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
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