- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937312
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
July 6, 2015 updated by: Alcon Research
Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SIMBRINZA
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
|
Other Names:
Other Names:
|
Placebo Comparator: Vehicle
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
|
Other Names:
Inactive ingredients used as a placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Diurnal Intraocular Pressure (IOP) at Week 6
Time Frame: 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).
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Diurnal IOP Change From Baseline to Week 6
Time Frame: Baseline, 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.
|
Baseline, Week 6
|
Mean Diurnal IOP Percentage Change From Baseline to Week 6
Time Frame: Baseline, 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.
|
Baseline, Week 6
|
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
Time Frame: Week 6
|
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).
|
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Steve Burmaster, PhD, Alcon Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 4, 2013
First Submitted That Met QC Criteria
September 6, 2013
First Posted (Estimate)
September 9, 2013
Study Record Updates
Last Update Posted (Estimate)
July 28, 2015
Last Update Submitted That Met QC Criteria
July 6, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Brimonidine Tartrate
- Travoprost
- Brinzolamide
Other Study ID Numbers
- M-13-020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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