Trial Outcomes & Findings for 24-hr Intraocular Pressure Control With SIMBRINZA ® (NCT NCT02770248)
NCT ID: NCT02770248
Last Updated: 2018-07-02
Results Overview
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
Baseline (Day 0), Week 4
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 16 study centers located in the United States.
Of the 162 enrolled, 37 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (125).
Participant milestones
| Measure |
SIMBRINZA
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
|
Overall Study
COMPLETED
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
SIMBRINZA
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Randomized in error, prior to treatment
|
0
|
1
|
Baseline Characteristics
24-hr Intraocular Pressure Control With SIMBRINZA ®
Baseline characteristics by cohort
| Measure |
SIMBRINZA
n=62 Participants
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
n=61 Participants
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Week 4Population: Full Analysis Set
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
SIMBRINZA
n=62 Participants
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
n=61 Participants
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
|
-3.09 mmHg
Interval -3.6 to -2.5
|
-0.60 mmHg
Interval -1.2 to -0.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 4Population: Full Analysis Set
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
SIMBRINZA
n=62 Participants
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
n=61 Participants
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Daytime IOP at Week 4
|
-3.93 mmHg
Interval -4.5 to -3.3
|
-0.51 mmHg
Interval -1.1 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 4Population: Full Analysis Set
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
SIMBRINZA
n=62 Participants
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
n=61 Participants
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
|
-1.88 mmHg
Interval -2.7 to -1.1
|
-0.73 mmHg
Interval -1.6 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 4Population: Full Analysis Set
IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
SIMBRINZA
n=62 Participants
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
Vehicle
n=61 Participants
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
|
|---|---|---|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
8AM
|
-3.28 mmHg
Interval -4.0 to -2.5
|
-0.49 mmHg
Interval -1.2 to 0.3
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
10AM
|
-5.05 mmHg
Interval -5.9 to -4.2
|
-0.61 mmHg
Interval -1.4 to 0.2
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
12PM
|
-4.03 mmHg
Interval -4.8 to -3.3
|
-0.27 mmHg
Interval -1.0 to 0.5
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
2PM
|
-3.36 mmHg
Interval -4.2 to -2.5
|
-0.66 mmHg
Interval -1.5 to 0.2
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
4PM
|
-3.95 mmHg
Interval -4.9 to -3.0
|
-0.51 mmHg
Interval -1.4 to 0.4
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
6PM
|
-4.46 mmHg
Interval -5.3 to -3.6
|
-0.32 mmHg
Interval -1.2 to 0.5
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
8PM
|
-3.42 mmHg
Interval -4.3 to -2.5
|
-0.72 mmHg
Interval -1.6 to 0.2
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
10PM
|
-2.10 mmHg
Interval -3.2 to -1.0
|
-0.67 mmHg
Interval -1.7 to 0.4
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
12AM
|
-1.79 mmHg
Interval -2.6 to -1.0
|
-0.83 mmHg
Interval -1.7 to 0.0
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
2AM
|
-2.30 mmHg
Interval -3.4 to -1.2
|
-0.55 mmHg
Interval -1.7 to 0.6
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
4AM
|
-1.42 mmHg
Interval -2.6 to -0.2
|
-0.98 mmHg
Interval -2.2 to 0.2
|
|
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
6AM
|
-1.95 mmHg
Interval -3.1 to -0.8
|
-0.63 mmHg
Interval -1.8 to 0.5
|
Adverse Events
SIMBRINZA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SIMBRINZA
n=64 participants at risk
All subjects exposed to SIMBRINZA
|
Vehicle
n=60 participants at risk
All subjects exposed to Vehicle
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/64 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
1.7%
1/60 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/64 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
1.7%
1/60 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/64 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
1.7%
1/60 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
Other adverse events
| Measure |
SIMBRINZA
n=64 participants at risk
All subjects exposed to SIMBRINZA
|
Vehicle
n=60 participants at risk
All subjects exposed to Vehicle
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/64 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
6.7%
4/60 • Day 0 treatment through study completion, an average of 4 weeks
An 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. Two subjects were administered both Investigational Products. For the Safety analysis, they are grouped under the first administered treatment. "As treated" analysis is reported.
|
Additional Information
Field Medical, Ophthalmology
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
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