Back to resultsEvaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
Timolol Maleate 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension, Simbrinza™, Intraocular Pressure
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
- Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
- Must sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
- Severe central visual field loss in either eye.
- Chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma or ocular surgery within the past 6 months.
- Ocular infection or ocular inflammation within the past 3 months.
- Clinically significant or progressive retinal disease.
- Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
- Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- Any medical condition that would preclude the safe administration of a topical beta-blocker.
- Cannot safely discontinue all glucocorticoids administered by any route.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIMBRINZA™
Timolol Maleate 0.5%
Arm Description
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
Outcomes
Primary Outcome Measures
Mean Nocturnal IOP at Week 4
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy 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 at Week 4
Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Mean 24-hour IOP at Week 4
24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy 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
NCT01978600
Brief Title
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 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 evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
Detailed Description
This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-Angle Glaucoma, Ocular Hypertension, Simbrinza™, Intraocular Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIMBRINZA™
Arm Type
Experimental
Arm Description
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
Arm Title
Timolol Maleate 0.5%
Arm Type
Active Comparator
Arm Description
Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
Other Intervention Name(s)
SIMBRINZA™
Intervention Description
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate 0.5%
Other Intervention Name(s)
TIMOPTIC™, TIMOPTIC-XE™, BETIMOL™, ISTALOL™
Intervention Description
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Primary Outcome Measure Information:
Title
Mean Nocturnal IOP at Week 4
Description
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
Secondary Outcome Measure Information:
Title
Mean Diurnal IOP at Week 4
Description
Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
Title
Mean 24-hour IOP at Week 4
Description
24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
Must sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
Severe central visual field loss in either eye.
Chronic, recurrent or severe inflammatory eye disease.
Ocular trauma or ocular surgery within the past 6 months.
Ocular infection or ocular inflammation within the past 3 months.
Clinically significant or progressive retinal disease.
Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Any medical condition that would preclude the safe administration of a topical beta-blocker.
Cannot safely discontinue all glucocorticoids administered by any route.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danyel Carr, MS
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
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