Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia (NCT NCT05294328)
NCT ID: NCT05294328
Last Updated: 2024-09-05
Results Overview
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
1 hour post treatment
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
Crossover Sequence 1 (123)
LNZ101 (1), LNZ100 (2), Vehicle (3)
|
Crossover Sequence 2 (231)
LNZ100 (2), Vehicle (3), LNZ101 (1)
|
Crossover Sequence 3 (312)
Vehicle (3), LNZ101 (1), LNZ100 (2)
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
24
|
|
Overall Study
COMPLETED
|
20
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
Crossover Sequence 1 (123)
LNZ101 (1), LNZ100 (2), Vehicle (3)
|
Crossover Sequence 2 (231)
LNZ100 (2), Vehicle (3), LNZ101 (1)
|
Crossover Sequence 3 (312)
Vehicle (3), LNZ101 (1), LNZ100 (2)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Other (Corneal Surface Disease and Distance VA)
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Baseline characteristics by cohort
| Measure |
Crossover Sequence 1 (123)
n=22 Participants
LNZ101 (1), LNZ100 (2), Vehicle (3)
|
Crossover Sequence 2 (231)
n=22 Participants
LNZ100 (2), Vehicle (3), LNZ101 (1)
|
Crossover Sequence 3 (312)
n=24 Participants
Vehicle (3), LNZ101 (1), LNZ100 (2)
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 6.02 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 6.04 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 6.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour post treatmentPopulation: The treatment crossover design allowed for each treatment to be analyzed in all subjects. The primary efficacy analysis was performed on a mITT population of subjects meeting the baseline criteria.
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
Outcome measures
| Measure |
LNZ101
n=50 Participants
LNZ101 (aceclidine hydrochloride and brimonidine tartrate) (non-preserved) Ophthalmic Solution
|
LNZ100
n=49 Participants
LNZ100 (Aceclidine hydrochloride) (non-preserved) Ophthalmic solution
|
Vehicle Ophthalmic Solution
n=51 Participants
Vehicle Proprietary Ophthalmic Solution
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
|
56.0 percentage of participants
|
71.4 percentage of participants
|
5.9 percentage of participants
|
Adverse Events
LNZ101
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LNZ100
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LNZ101
n=62 participants at risk
LNZ101 (aceclidine hydrochloride and brimonidine tartrate) (non-preserved) Ophthalmic Solution
|
LNZ100
n=62 participants at risk
LNZ100 (Aceclidine hydrochloride) (non-preserved) Ophthalmic solution
|
Vehicle Ophthalmic Solution
n=61 participants at risk
Proprietary Vehicle ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
Ocular Vision Blurred
|
0.00%
0/62 • Approximately 3 weeks
|
0.00%
0/62 • Approximately 3 weeks
|
11.5%
7/61 • Approximately 3 weeks
|
|
Nervous system disorders
Non-Ocular Headache
|
14.5%
9/62 • Approximately 3 weeks
|
4.8%
3/62 • Approximately 3 weeks
|
1.6%
1/61 • Approximately 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER