Back to resultsSIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Brinz/brim vehicle
Prostaglandin analogue
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either open-angle glaucoma or ocular hypertension;
- Must sign an informed consent form;
- Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
- Willing and able to attend all study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
- Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
- Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
- Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SIMBRINZA + PGA
Vehicle + PGA
Arm Description
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
Outcomes
Primary Outcome Measures
Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Secondary Outcome Measures
Mean Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Mean Change From Baseline in IOP at 11:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Mean Change From Baseline in IOP at 09:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Mean Percentage Change From Baseline at 09:00 at Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419508
Brief Title
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Official Title
Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2015 (Actual)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
Detailed Description
This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIMBRINZA + PGA
Arm Type
Experimental
Arm Description
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
Arm Title
Vehicle + PGA
Arm Type
Other
Arm Description
Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Other Intervention Name(s)
SIMBRINZA® suspension
Intervention Type
Drug
Intervention Name(s)
Brinz/brim vehicle
Intervention Description
Inactive ingredients used as a placebo for masking purposes
Intervention Type
Drug
Intervention Name(s)
Prostaglandin analogue
Other Intervention Name(s)
TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)
Primary Outcome Measure Information:
Title
Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Mean Diurnal IOP at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Time Frame
Week 6
Title
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
Title
Mean Change From Baseline in IOP at 11:00 at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
Title
Mean Percentage Change From Baseline in IOP at 11:00 at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
Title
Mean Change From Baseline in IOP at 09:00 at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
Title
Mean Percentage Change From Baseline at 09:00 at Week 6
Description
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of either open-angle glaucoma or ocular hypertension;
Must sign an informed consent form;
Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
Willing and able to attend all study visits;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Ophtha, GCRA
Organizational Affiliation
Alcon, a Novartis Company
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
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