Trial Outcomes & Findings for Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia (NCT NCT05270863)
NCT ID: NCT05270863
Last Updated: 2024-10-15
Results Overview
Primary endpoint measure at hour 1 post-dose at study visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Day 1 Hour 1
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
B, C, BF
Crossover design with 3 study treatments. Participants received Brimonidine, Carbachol PF, or BRIMOCHOL PF.
|
B, BF, C
Crossover design with 3 study treatments. Participants received Brimonidine, BRIMOCHOL PF, or Carbachol PF.
|
C, B, BF
Crossover design with 3 study treatments. Participants received Carbachol PF, Brimonidine, or BRIMOCHOL PF.
|
C, BF, B
Crossover design with 3 study treatments. Participants received Carbachol PF, BRIMOCHOL PF, or Brimonidine
|
BF, B, C
Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Brimonidine, or Carbachol PF.
|
BF, C, B
Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Carbachol PF, or Brimonidine.
|
|---|---|---|---|---|---|---|
|
Visit 2 First Intervention
STARTED
|
31
|
30
|
30
|
30
|
31
|
30
|
|
Visit 2 First Intervention
COMPLETED
|
31
|
30
|
30
|
29
|
31
|
30
|
|
Visit 2 First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
First Washout
STARTED
|
31
|
30
|
30
|
29
|
31
|
30
|
|
First Washout
COMPLETED
|
31
|
30
|
30
|
29
|
30
|
28
|
|
First Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Visit 3 Second Intervention
STARTED
|
31
|
30
|
30
|
29
|
30
|
28
|
|
Visit 3 Second Intervention
COMPLETED
|
30
|
30
|
29
|
29
|
30
|
28
|
|
Visit 3 Second Intervention
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Second Washout
STARTED
|
30
|
30
|
29
|
29
|
30
|
28
|
|
Second Washout
COMPLETED
|
29
|
29
|
29
|
28
|
30
|
28
|
|
Second Washout
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Visit 4 Third Invervention
STARTED
|
29
|
29
|
29
|
28
|
30
|
28
|
|
Visit 4 Third Invervention
COMPLETED
|
29
|
29
|
29
|
28
|
30
|
28
|
|
Visit 4 Third Invervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
B, C, BF
Crossover design with 3 study treatments. Participants received Brimonidine, Carbachol PF, or BRIMOCHOL PF.
|
B, BF, C
Crossover design with 3 study treatments. Participants received Brimonidine, BRIMOCHOL PF, or Carbachol PF.
|
C, B, BF
Crossover design with 3 study treatments. Participants received Carbachol PF, Brimonidine, or BRIMOCHOL PF.
|
C, BF, B
Crossover design with 3 study treatments. Participants received Carbachol PF, BRIMOCHOL PF, or Brimonidine
|
BF, B, C
Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Brimonidine, or Carbachol PF.
|
BF, C, B
Crossover design with 3 study treatments. Participants received BRIMOCHOL PF, Carbachol PF, or Brimonidine.
|
|---|---|---|---|---|---|---|
|
Visit 2 First Intervention
Randomization error
|
0
|
0
|
0
|
1
|
0
|
0
|
|
First Washout
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
|
First Washout
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Visit 3 Second Intervention
Inclusion Criteria
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Second Washout
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Second Washout
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
Baseline characteristics by cohort
| Measure |
All Subjects
n=182 Participants
3 study treatments across 4 study visits
|
|---|---|
|
Age, Continuous
|
55 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
182 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 Hour 1Population: All participants who received at least one dose of study treatment (mITT)
Primary endpoint measure at hour 1 post-dose at study visit
Outcome measures
| Measure |
BRIMOCHOL™ PF
n=178 Participants
A single drop in each eye at a visit.
BRIMOCHOL™ PF: A single drop in each eye at a visit.
|
Carbachol PF
n=177 Participants
A single drop in each eye at a visit.
Carbachol PF: A single drop in each eye at a visit.
|
Brimonidine Tartrate
n=176 Participants
A single drop in each eye at a visit.
Brimonidine tartrate: A single drop in each eye at a visit.
|
|---|---|---|---|
|
Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity
|
49.4 Percentage of participants
Interval 41.9 to 57.0
|
35.0 Percentage of participants
Interval 28.0 to 42.5
|
22.7 Percentage of participants
Interval 16.8 to 29.6
|
Adverse Events
BRIMOCHOL™ PF
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Carbachol PF
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Brimonidine Tartrate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BRIMOCHOL™ PF
n=178 participants at risk
A single drop in each eye at a visit.
BRIMOCHOL™ PF: A single drop in each eye at a visit.
|
Carbachol PF
n=177 participants at risk
A single drop in each eye at a visit.
Carbachol PF: A single drop in each eye at a visit.
|
Brimonidine Tartrate
n=176 participants at risk
A single drop in each eye at a visit.
Brimonidine tartrate: A single drop in each eye at a visit.
|
|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
1/178 • Number of events 1 • 45 Days
|
0.00%
0/177 • 45 Days
|
0.00%
0/176 • 45 Days
|
Other adverse events
| Measure |
BRIMOCHOL™ PF
n=178 participants at risk
A single drop in each eye at a visit.
BRIMOCHOL™ PF: A single drop in each eye at a visit.
|
Carbachol PF
n=177 participants at risk
A single drop in each eye at a visit.
Carbachol PF: A single drop in each eye at a visit.
|
Brimonidine Tartrate
n=176 participants at risk
A single drop in each eye at a visit.
Brimonidine tartrate: A single drop in each eye at a visit.
|
|---|---|---|---|
|
Eye disorders
Eye Irritation
|
14.0%
25/178 • 45 Days
|
11.3%
20/177 • 45 Days
|
0.57%
1/176 • 45 Days
|
|
Nervous system disorders
Headache
|
9.0%
16/178 • 45 Days
|
2.8%
5/177 • 45 Days
|
0.57%
1/176 • 45 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place