Back to resultsSafety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Brinzolamide/brimonidine vehicle
Travoprost 0.004%/timolol 0.5% solution
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
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.
Sites / Locations
- Contact Alcon for Locations (Europe, Asia, and Latin America)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simbrinza + Duotrav
Vehicle + Duotrav
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at 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.
Secondary Outcome Measures
Mean Diurnal IOP at 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.
Mean Percentage Change From Baseline in Diurnal IOP at 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.
Mean Change From Baseline in IOP (09:00, 11:00) at 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.
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02730871
Brief Title
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
Official Title
Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment Challenges
Study Start Date
June 24, 2016 (Actual)
Primary Completion Date
July 13, 2018 (Actual)
Study Completion Date
July 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simbrinza + Duotrav
Arm Type
Experimental
Arm Description
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)
Arm Title
Vehicle + Duotrav
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Other Intervention Name(s)
SIMBRINZA® suspension
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/brimonidine vehicle
Intervention Description
Inactive ingredients used as placebo comparator
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/timolol 0.5% solution
Other Intervention Name(s)
DUOTRAV®
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
Description
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.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Mean Diurnal IOP at Week 6
Description
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.
Time Frame
Week 6
Title
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
Description
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.
Time Frame
Baseline, 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc Global Trial Director, TM Ophtha
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon for Locations (Europe, Asia, and Latin America)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
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