Back to resultsEffect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Primary Purpose
Ocular Hypertension, Open Angle Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Vehicle
Prostaglandin analogue
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring glaucoma, prostaglandin analogue, brinzolamide, brimonidine
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
- Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
- Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
- Able to understand and sign Informed Consent Document;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
- Any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Severe central visual field loss;
- Chronic, recurrent, or severe inflammatory eye disease;
- Ocular trauma within the past 6 months;
- Ocular infection or ocular inflammation within the past 3 months;
- Best-corrected visual acuity score worse than approximately 20/80 Snellen;
- Eye surgery within the past 6 months;
- Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
- Use of any additional topical or systemic ocular hypertensive medication during the study;
- Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SIMBRINZA
Vehicle
Arm Description
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Outcomes
Primary Outcome Measures
Mean Diurnal Intraocular Pressure (IOP) at Week 6
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Secondary Outcome Measures
Mean Diurnal IOP Change From Baseline to Week 6
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Mean Diurnal IOP Percentage Change From Baseline to Week 6
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01937312
Brief Title
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Official Title
Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (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 demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
Detailed Description
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma
Keywords
glaucoma, prostaglandin analogue, brinzolamide, brimonidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIMBRINZA
Arm Type
Experimental
Arm Description
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Other Intervention Name(s)
SIMBRINZA® Suspension
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Intervention Type
Drug
Intervention Name(s)
Prostaglandin analogue
Other Intervention Name(s)
TRAVATAN Z®, LUMIGAN®, XALATAN®
Primary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP) at Week 6
Description
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Mean Diurnal IOP Change From Baseline to Week 6
Description
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Time Frame
Baseline, Week 6
Title
Mean Diurnal IOP Percentage Change From Baseline to Week 6
Description
Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
Time Frame
Baseline, Week 6
Title
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
Description
IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
Able to understand and sign Informed Consent Document;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
Any form of glaucoma other than open angle glaucoma or ocular hypertension;
Severe central visual field loss;
Chronic, recurrent, or severe inflammatory eye disease;
Ocular trauma within the past 6 months;
Ocular infection or ocular inflammation within the past 3 months;
Best-corrected visual acuity score worse than approximately 20/80 Snellen;
Eye surgery within the past 6 months;
Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
Use of any additional topical or systemic ocular hypertensive medication during the study;
Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Burmaster, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
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