Trial Outcomes & Findings for Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia (NCT NCT04774237)
NCT ID: NCT04774237
Last Updated: 2025-02-05
Results Overview
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Day 1, Hour 1 post-dose
Results posted on
2025-02-05
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
|
2
|
5
|
3
|
2
|
3
|
3
|
|
Visit 2 First Intervention
COMPLETED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Visit 2 First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
First Washout
STARTED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
First Washout
COMPLETED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
First Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 3 Second Intervention
STARTED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Visit 3 Second Intervention
COMPLETED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Visit 3 Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Washout
STARTED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Second Washout
COMPLETED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Second Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 4 Third Intervention
STARTED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Visit 4 Third Intervention
COMPLETED
|
2
|
5
|
3
|
2
|
2
|
3
|
|
Visit 4 Third Intervention
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
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Baseline characteristics by cohort
| Measure |
Single Drop Cohort
n=18 Participants
A single drop in each eye at a visit.
|
|---|---|
|
Age, Continuous
|
52.3 Years
STANDARD_DEVIATION 4.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Hour 1 post-dosePrimary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Outcome measures
| Measure |
BRIMOCHOL
n=17 Participants
Single drop cohort
|
BRIMOCHOL PF
n=18 Participants
Single drop cohort
|
Carbachol PF
n=17 Participants
Single drop cohort
|
|---|---|---|---|
|
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
|
15 Participants
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 1, Hour 1 post-doseSecondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Outcome measures
| Measure |
BRIMOCHOL
n=17 Participants
Single drop cohort
|
BRIMOCHOL PF
n=18 Participants
Single drop cohort
|
Carbachol PF
n=17 Participants
Single drop cohort
|
|---|---|---|---|
|
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
|
2.4 ETDRS letters
Standard Deviation 3.39
|
2.8 ETDRS letters
Standard Deviation 3.28
|
3.1 ETDRS letters
Standard Deviation 2.86
|
Adverse Events
BRIMOCHOL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
BRIMOCHOL PF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Carbachol PF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRIMOCHOL
n=17 participants at risk
Single drop cohort
|
BRIMOCHOL PF
n=18 participants at risk
Single drop cohort
|
Carbachol PF
n=17 participants at risk
Single drop cohort
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
5.9%
1/17 • Number of events 1 • 30 days
|
0.00%
0/18 • 30 days
|
0.00%
0/17 • 30 days
|
|
Eye disorders
Eye pain
|
0.00%
0/17 • 30 days
|
5.6%
1/18 • Number of events 1 • 30 days
|
0.00%
0/17 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place