Trial Outcomes & Findings for Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV® (NCT NCT02730871)
NCT ID: NCT02730871
Last Updated: 2019-05-29
Results Overview
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.
TERMINATED
PHASE4
173 participants
Baseline, Week 6
2019-05-29
Participant Flow
Subjects were recruited from sites located in Argentina, Australia, Belgium, Chile, Columbia, Germany, Greece, Italy, Malaysia, Poland, Spain, Taiwan, and the United Kingdom.
Of the 173 enrolled, 39 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
Full Analysis Set (FAS)
|
67
|
67
|
|
Overall Study
Safety Analysis Set
|
67
|
67
|
|
Overall Study
COMPLETED
|
61
|
67
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
0
|
Baseline Characteristics
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
Baseline characteristics by cohort
| Measure |
Simbrinza + Duotrav
n=67 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 13.47 • n=99 Participants
|
65.7 years
STANDARD_DEVIATION 11.77 • n=107 Participants
|
65.7 years
STANDARD_DEVIATION 12.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Intraocular Pressure (IOP)
|
21.6 mmHg
STANDARD_DEVIATION 1.78 • n=99 Participants
|
21.8 mmHg
STANDARD_DEVIATION 1.90 • n=107 Participants
|
21.7 mmHg
STANDARD_DEVIATION 1.84 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
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.
Outcome measures
| Measure |
Simbrinza + Duotrav
n=61 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
|---|---|---|
|
Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
|
-4.5 mmHg
Standard Deviation 2.69
|
-2.4 mmHg
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Week 6Population: Full Analysis Set with non-missing values
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.
Outcome measures
| Measure |
Simbrinza + Duotrav
n=61 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
|---|---|---|
|
Mean Diurnal IOP at Week 6
|
17.1 mmHg
Standard Deviation 2.96
|
19.4 mmHg
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
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.
Outcome measures
| Measure |
Simbrinza + Duotrav
n=61 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
|---|---|---|
|
Mean Percentage Change From Baseline in Diurnal IOP at Week 6
|
-20.7 percentage change
Standard Deviation 12.00
|
-11.1 percentage change
Standard Deviation 13.86
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
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.
Outcome measures
| Measure |
Simbrinza + Duotrav
n=67 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
|---|---|---|
|
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Baseline 9:00 Hr
|
22.2 mmHg
Standard Deviation 1.84
|
22.5 mmHg
Standard Deviation 1.80
|
|
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Baseline 11:00 Hr
|
21.4 mmHg
Standard Deviation 1.93
|
21.4 mmHg
Standard Deviation 2.26
|
|
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Change from Baseline 9:00 Hr
|
-4.4 mmHg
Standard Deviation 3.07
|
-3.2 mmHg
Standard Deviation 3.40
|
|
Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
Change from Baseline 11:00 Hr
|
-5.4 mmHg
Standard Deviation 2.84
|
-2.5 mmHg
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included in the calculation of change.
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.
Outcome measures
| Measure |
Simbrinza + Duotrav
n=61 Participants
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)
|
Vehicle + Duotrav
n=67 Participants
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)
|
|---|---|---|
|
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
Percent change at 9:00 Hr
|
-20.2 percentage change
Standard Deviation 13.56
|
-14.1 percentage change
Standard Deviation 15.10
|
|
Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
Percent change at 11:00 Hr
|
-25.0 percentage change
Standard Deviation 12.73
|
-11.7 percentage change
Standard Deviation 13.63
|
Adverse Events
Simbrinza + Duotrav
Vehicle + Duotrav
Serious adverse events
| Measure |
Simbrinza + Duotrav
n=67 participants at risk
All subjects exposed to brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension plus travoprost 0.004%/timolol 0.5% solution
|
Vehicle + Duotrav
n=67 participants at risk
All subjects exposed to brinzolamide/brimonidine vehicle plus travoprost 0.004%/timolol 0.5% solution
|
|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/67 • Baseline through study completion, an average of 42 days
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Includes all subjects who received a dose of masked investigational product (Safety Analysis Set).
|
1.5%
1/67 • Baseline through study completion, an average of 42 days
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Includes all subjects who received a dose of masked investigational product (Safety Analysis Set).
|
Other adverse events
Adverse event data not reported
Additional Information
WW Brand Medical Director Ophtha, GMA Ophthalmics
Alcon, A Novartis Division
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER