Trial Outcomes & Findings for To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes (NCT NCT04944290)
NCT ID: NCT04944290
Last Updated: 2025-04-02
Results Overview
mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
447 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
Perrigo Active
Brinzolamide/brimonidine ophthalmic suspension: Test product
|
Reference Active
Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Overall Study
STARTED
|
221
|
226
|
|
Overall Study
COMPLETED
|
204
|
214
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
Baseline characteristics by cohort
| Measure |
Perrigo Active
n=221 Participants
Brinzolamide/brimonidine ophthalmic suspension: Test product
|
Reference Active
n=226 Participants
Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
155 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 10.31 • n=7 Participants
|
66.35 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
221 participants
n=5 Participants
|
226 participants
n=7 Participants
|
447 participants
n=5 Participants
|
|
Iris color
Right eye - Dark
|
147 participants
n=5 Participants
|
145 participants
n=7 Participants
|
292 participants
n=5 Participants
|
|
Iris color
Right eye - Light
|
74 participants
n=5 Participants
|
81 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Iris color
Left eye - Dark
|
148 participants
n=5 Participants
|
145 participants
n=7 Participants
|
293 participants
n=5 Participants
|
|
Iris color
Left eye - Light
|
73 participants
n=5 Participants
|
81 participants
n=7 Participants
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksmean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement
Outcome measures
| Measure |
Perrigo Active
n=187 Participants
Brinzolamide/brimonidine ophthalmic suspension: Test product
|
Reference Active
n=193 Participants
Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Mean Change in Intra-ocular Pressure
8AM Day 42
|
-5.07 mmHG
Standard Deviation 2.796
|
-5.03 mmHG
Standard Deviation 2.997
|
|
Mean Change in Intra-ocular Pressure
8AM Day 14
|
-5.30 mmHG
Standard Deviation 3.181
|
-5.16 mmHG
Standard Deviation 3.030
|
|
Mean Change in Intra-ocular Pressure
10AM Day 14
|
-6.92 mmHG
Standard Deviation 2.990
|
-6.57 mmHG
Standard Deviation 3.130
|
|
Mean Change in Intra-ocular Pressure
10AM Day 42
|
-6.53 mmHG
Standard Deviation 3.129
|
-6.37 mmHG
Standard Deviation 3.152
|
Adverse Events
Perrigo Active
Serious events: 2 serious events
Other events: 32 other events
Deaths: 1 deaths
Reference Active
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perrigo Active
n=221 participants at risk
Brinzolamide/brimonidine ophthalmic suspension: Test product
|
Reference Active
n=226 participants at risk
Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.45%
1/221 • Number of events 1 • Day 1 to Day 46
|
0.00%
0/226 • Day 1 to Day 46
|
|
Cardiac disorders
coronary heart disease
|
0.00%
0/221 • Day 1 to Day 46
|
0.44%
1/226 • Number of events 1 • Day 1 to Day 46
|
|
Nervous system disorders
subarachnoid hemorrhage
|
0.00%
0/221 • Day 1 to Day 46
|
0.44%
1/226 • Number of events 1 • Day 1 to Day 46
|
|
Nervous system disorders
Worsening of Left Carotid Artery Stenosis
|
0.00%
0/221 • Day 1 to Day 46
|
0.44%
1/226 • Number of events 1 • Day 1 to Day 46
|
|
Nervous system disorders
acute right temporal ischemic stroke
|
0.00%
0/221 • Day 1 to Day 46
|
0.44%
1/226 • Number of events 1 • Day 1 to Day 46
|
|
Infections and infestations
COVID-19 virus infection
|
0.45%
1/221 • Number of events 1 • Day 1 to Day 46
|
0.00%
0/226 • Day 1 to Day 46
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidoses
|
0.45%
1/221 • Number of events 1 • Day 1 to Day 46
|
0.00%
0/226 • Day 1 to Day 46
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure with hypoxia
|
0.45%
1/221 • Number of events 1 • Day 1 to Day 46
|
0.00%
0/226 • Day 1 to Day 46
|
Other adverse events
| Measure |
Perrigo Active
n=221 participants at risk
Brinzolamide/brimonidine ophthalmic suspension: Test product
|
Reference Active
n=226 participants at risk
Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Eye disorders
Vision blurred
|
7.2%
16/221 • Number of events 221 • Day 1 to Day 46
|
5.3%
12/226 • Number of events 226 • Day 1 to Day 46
|
|
Nervous system disorders
Dysgeusia
|
7.2%
16/221 • Number of events 221 • Day 1 to Day 46
|
4.4%
10/226 • Number of events 226 • Day 1 to Day 46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60