- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730871
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
May 16, 2019 updated by: Alcon Research
Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)
The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.
Study Overview
Status
Terminated
Conditions
Detailed Description
This study is divided into 2 sequential phases for a total of 5 visits.
Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits.
Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon for Locations (Europe, Asia, and Latin America)
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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 pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.
- Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.
- Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.
- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.
- Willing and able to attend all study visits.
Exclusion Criteria:
- Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.
- Any form of glaucoma other than open-angle glaucoma or ocular hypertension.
- Severe central visual field loss in either eye.
- Chronic, recurrent or severe inflammatory eye disease in either eye.
- Ocular trauma in either eye within the past 6 months prior to the Screening visit.
- Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit.
- Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.
- Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication.
- Intraocular surgery in either eye within the past 6 months prior to the Screening visit.
- Ocular laser surgery in either eye within the past 3 months prior to the Screening visit.
- Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study.
- Asthma, history of asthma, or severe chronic obstructive pulmonary disease.
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 + Duotrav
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
|
Other Names:
1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
Other Names:
|
Placebo Comparator: Vehicle + Duotrav
Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
|
1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
Other Names:
Inactive ingredients used as placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
Time Frame: Baseline, Week 6
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry.
Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM).
A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Only one eye (study eye) was used for the analyses.
|
Baseline, Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Diurnal IOP at Week 6
Time Frame: Week 6
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry.
Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM).
A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Only one eye (study eye) was used for the analyses.
|
Week 6
|
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
Time Frame: Baseline, Week 6
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry.
Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM).
A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Only one eye (study eye) was used for the analyses.
|
Baseline, Week 6
|
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Time Frame: Baseline, Week 6
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry.
A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Only one eye (study eye) was used for the analyses.
|
Baseline, Week 6
|
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
Time Frame: Baseline, Week 6
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry.
A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Only one eye (study eye) was used for the analyses.
|
Baseline, Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Assoc Global Trial Director, TM Ophtha, 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 (Actual)
June 24, 2016
Primary Completion (Actual)
July 13, 2018
Study Completion (Actual)
July 13, 2018
Study Registration Dates
First Submitted
March 30, 2016
First Submitted That Met QC Criteria
April 6, 2016
First Posted (Estimate)
April 7, 2016
Study Record Updates
Last Update Posted (Actual)
May 29, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Timolol
- Brimonidine Tartrate
- Travoprost
- Brinzolamide
Other Study ID Numbers
- GLJ576-P001
- 2016-000176-20 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
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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