Back to resultsA Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fixed-Combination Bimatoprost/Brimonidine
Bimatoprost Ophthalmic Solution 0.01%
Vehicle Ophthalmic Solution
Brimonidine Tartrate Ophthalmic Solution 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ocular hypertension or glaucoma
- Requires intraocular pressure (IOP)-lowering therapy
Exclusion Criteria:
- Cataract surgery in one eye
- Ocular laser or intraocular surgery within 6 months
- Refractive surgery in either eye
- Anticipated use of contact lenses during the study
- Expected use of artificial tears during the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Fixed-Combination Bimatoprost/Brimonidine
Bimatoprost Ophthalmic Solution 0.01% and Vehicle
Brimonidine Tartrate Ophthalmic Solution 0.2%
Arm Description
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Secondary Outcome Measures
Change From Baseline in Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Average Eye Mean Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863953
Brief Title
A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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 is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed-Combination Bimatoprost/Brimonidine
Arm Type
Experimental
Arm Description
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Arm Title
Bimatoprost Ophthalmic Solution 0.01% and Vehicle
Arm Type
Active Comparator
Arm Description
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Arm Title
Brimonidine Tartrate Ophthalmic Solution 0.2%
Arm Type
Active Comparator
Arm Description
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Fixed-Combination Bimatoprost/Brimonidine
Intervention Description
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost Ophthalmic Solution 0.01%
Other Intervention Name(s)
LUMIGAN
Intervention Description
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle Ophthalmic Solution
Intervention Description
One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate Ophthalmic Solution 0.2%
Other Intervention Name(s)
ALPHAGAN
Intervention Description
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame
Baseline, Day 42
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Eye Mean Diurnal IOP
Description
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame
Baseline, Day 14, Day 28
Title
Average Eye Mean Diurnal IOP
Description
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Time Frame
Day 14, Day 28, Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ocular hypertension or glaucoma
Requires intraocular pressure (IOP)-lowering therapy
Exclusion Criteria:
Cataract surgery in one eye
Ocular laser or intraocular surgery within 6 months
Refractive surgery in either eye
Anticipated use of contact lenses during the study
Expected use of artificial tears during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
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