Trial Outcomes & Findings for A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia (NCT NCT03201562)
NCT ID: NCT03201562
Last Updated: 2022-09-22
Results Overview
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
1 hour post-treatment
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Crossover Sequence 1
Aceclidine+tropicamide combination Visit 1, Aceclidine Visit 2, Vehicle Visit 3
|
Crossover Sequence 2
Aceclidine Visit 1, Vehicle Visit 2, Aceclidine+tropicamide combination Visit 3
|
Crossover Sequence 3
Vehicle Visit 1, Aceclidine+tropicamide combination Visit 2, Aceclidine Visit 3
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
Crossover Sequence 1
Aceclidine+tropicamide combination Visit 1, Aceclidine Visit 2, Vehicle Visit 3
|
Crossover Sequence 2
Aceclidine Visit 1, Vehicle Visit 2, Aceclidine+tropicamide combination Visit 3
|
Crossover Sequence 3
Vehicle Visit 1, Aceclidine+tropicamide combination Visit 2, Aceclidine Visit 3
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
Baseline Characteristics
A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Baseline characteristics by cohort
| Measure |
Crossover Sequence 1
n=18 Participants
Aceclidine+tropicamide combination Visit 1, Aceclidine Visit 2, Vehicle Visit 3
|
Crossover Sequence 2
n=20 Participants
Aceclidine Visit 1, Vehicle Visit 2, Aceclidine+tropicamide combination Visit 3
|
Crossover Sequence 3
n=20 Participants
Vehicle Visit 1, Aceclidine+tropicamide combination Visit 2, Aceclidine Visit 3
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 3.29 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 4.28 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 4.51 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 4.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour post-treatmentPopulation: The treatment crossover design allowed for each treatment to be analyzed in all 58 subjects. The primary efficacy analysis was performed on a mITT population of subjects meeting the baseline criteria.
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
Outcome measures
| Measure |
Aceclidine+Tropicamide Combination
n=36 Participants
Aceclidine+tropicamide combination single dose
|
Aceclidine
n=36 Participants
Aceclidine single dose
|
Vehicle
n=42 Participants
Vehicle single dose
|
|---|---|---|---|
|
Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye
|
47.22 percentage of participants
|
47.22 percentage of participants
|
2.38 percentage of participants
|
Adverse Events
Aceclidine+Tropicamide Combination
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Aceclidine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aceclidine+Tropicamide Combination
n=54 participants at risk
Aceclidine+tropicamide combination single dose
|
Aceclidine
n=54 participants at risk
Aceclidine single dose
|
Vehicle
n=57 participants at risk
Vehicle single dose
|
|---|---|---|---|
|
Eye disorders
Instillation site pain (mild)
|
31.5%
17/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
29.6%
16/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
10.5%
6/57 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
|
Eye disorders
Instillation site pain (moderate)
|
3.7%
2/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
9.3%
5/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
7.0%
4/57 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
|
Eye disorders
Ocular hyperaemia
|
5.6%
3/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
0.00%
0/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
0.00%
0/57 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
5.6%
3/54 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
0.00%
0/57 • Adverse Events were collected for up to 50 days.
Safety population includes all randomized subjects who receive at least one dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI must not present the study results until the aggregate multi-site study results are published. The PI must submit to sponsor any proposed publication or presentation at least 60 days prior to the submission. Sponsor may require the delay of publication or presentation for an additional period of time not to exceed 120 days for the purposes of filing patent applications to patentable subject matter or the resolution of any inaccuracies or misleading statements.
- Publication restrictions are in place
Restriction type: OTHER