Back to results24-hr Intraocular Pressure Control With SIMBRINZA ®
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of either open-angle glaucoma or ocular hypertension;
- Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
- Willing and able to sign an informed consent form;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
- Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Ocular surgeries or procedures excluded by the protocol;
- Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
- Other protocol-specific exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIMBRINZA
Vehicle
Arm Description
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Outcomes
Primary Outcome Measures
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Secondary Outcome Measures
Least Squares Mean Change From Baseline in Daytime IOP at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02770248
Brief Title
24-hr Intraocular Pressure Control With SIMBRINZA ®
Official Title
24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
January 14, 2017 (Actual)
Study Completion Date
January 14, 2017 (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 evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.
Detailed Description
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIMBRINZA
Arm Type
Experimental
Arm Description
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Arm Title
Vehicle
Arm Type
Active Comparator
Arm Description
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Other Intervention Name(s)
SIMBRINZA ®
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Inactive ingredients used as a placebo for masking purposes
Primary Outcome Measure Information:
Title
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
Description
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Week 4
Secondary Outcome Measure Information:
Title
Least Squares Mean Change From Baseline in Daytime IOP at Week 4
Description
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Week 4
Title
Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
Description
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Week 4
Title
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
Description
IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time Frame
Baseline (Day 0), Week 4
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;
Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
Willing and able to sign an informed consent form;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
Ocular surgeries or procedures excluded by the protocol;
Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
Other protocol-specific exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, GCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Learn more about this trial
24-hr Intraocular Pressure Control With SIMBRINZA ®
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