Back to resultsSafety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
brimonidine tartrate/timolol fixed combination ophthalmic solution
brimonidine tartrate ophthalmic solution
timolol ophthalmic solution
fixed combination vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
- No anticipated wearing of contact lenses during study
Exclusion Criteria:
- Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
- Required regular use of other ocular medications except for occasional use of artificial tears
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Combigan®
Alphagan® and Timolol Concurrent
Arm Description
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229462
Brief Title
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combigan®
Arm Type
Other
Arm Description
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Arm Title
Alphagan® and Timolol Concurrent
Arm Type
Active Comparator
Arm Description
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate/timolol fixed combination ophthalmic solution
Other Intervention Name(s)
Combigan®
Intervention Description
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Intervention Type
Drug
Intervention Name(s)
brimonidine tartrate ophthalmic solution
Other Intervention Name(s)
Alphagan®
Intervention Description
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Intervention Type
Drug
Intervention Name(s)
timolol ophthalmic solution
Intervention Description
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Intervention Type
Other
Intervention Name(s)
fixed combination vehicle
Intervention Description
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Description
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
No anticipated wearing of contact lenses during study
Exclusion Criteria:
Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
Required regular use of other ocular medications except for occasional use of artificial tears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
We'll reach out to this number within 24 hrs