Trial Outcomes & Findings for To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes (NCT NCT04024072)
NCT ID: NCT04024072
Last Updated: 2023-03-06
Results Overview
mean change in intra-ocular pressure of both eyes 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
495 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Perrigo Active
Test product
Brinzolamide 1% ophthalmic suspension: Test product
|
Reference Active
Azopt ophthalmic suspension
Azopt 1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
246
|
|
Overall Study
COMPLETED
|
247
|
237
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare the Safety and Efficacy 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=249 Participants
Test product
Brinzolamide 1% ophthalmic suspension: Test product
|
Reference Active
n=246 Participants
Azopt ophthalmic suspension
Azopt 1% Ophthalmic Suspension: Reference product
|
Total
n=495 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
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
151 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 11.12 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
81 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color
Right eye · Dark
|
158 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Iris Color
Right eye · Light
|
91 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Iris Color
Left eye · Dark
|
158 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Iris Color
Left eye · Light
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Per-protocol population
mean change in intra-ocular pressure of both eyes 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.
Outcome measures
| Measure |
Perrigo Active
n=228 Participants
Test product
Brinzolamide 1% ophthalmic suspension: Test product
|
Reference Active
n=219 Participants
Azopt ophthalmic suspension
Azopt 1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Mean Change in Intra-ocular Pressure
8AM Day 14
|
-4.25 mmHG
Standard Deviation 2.713
|
-3.80 mmHG
Standard Deviation 2.719
|
|
Mean Change in Intra-ocular Pressure
10AM Day 14
|
-4.22 mmHG
Standard Deviation 2.722
|
-4.00 mmHG
Standard Deviation 2.756
|
|
Mean Change in Intra-ocular Pressure
8AM Day 42
|
-4.43 mmHG
Standard Deviation 2.967
|
-4.20 mmHG
Standard Deviation 2.591
|
|
Mean Change in Intra-ocular Pressure
10AM Day 42
|
-4.05 mmHG
Standard Deviation 2.961
|
-4.06 mmHG
Standard Deviation 2.842
|
Adverse Events
Perrigo Active
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Reference Active
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perrigo Active
n=249 participants at risk
Test product
Brinzolamide 1% ophthalmic suspension: Test product
|
Reference Active
n=246 participants at risk
Azopt ophthalmic suspension
Azopt 1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/249 • Day 1 to Day 46
|
0.41%
1/246 • Number of events 1 • Day 1 to Day 46
|
Other adverse events
| Measure |
Perrigo Active
n=249 participants at risk
Test product
Brinzolamide 1% ophthalmic suspension: Test product
|
Reference Active
n=246 participants at risk
Azopt ophthalmic suspension
Azopt 1% Ophthalmic Suspension: Reference product
|
|---|---|---|
|
Eye disorders
vision blurred
|
3.6%
9/249 • Number of events 9 • Day 1 to Day 46
|
6.1%
15/246 • Number of events 15 • Day 1 to Day 46
|
|
Nervous system disorders
Dysgeusia
|
9.2%
23/249 • Number of events 23 • Day 1 to Day 46
|
8.5%
21/246 • Number of events 21 • Day 1 to Day 46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place