Trial Outcomes & Findings for Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects (NCT NCT05753189)
NCT ID: NCT05753189
Last Updated: 2026-05-13
Results Overview
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
7 visits over a total duration of approximately 28 weeks
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Aceclidine + Brimonidine (LNZ101)
LNZ101: Aceclidine + Brimonidine ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
LNZ100: Aceclidine ophthalmic solution Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
Vehicle ophthalmic solution Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
144
|
144
|
74
|
|
Overall Study
Safety Population
|
144
|
144
|
73
|
|
Overall Study
COMPLETED
|
94
|
121
|
69
|
|
Overall Study
NOT COMPLETED
|
50
|
23
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects
Baseline characteristics by cohort
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=144 Participants
LNZ101: Aceclidine + Brimonidine ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=144 Participants
LNZ100: Aceclidine ophthalmic solution Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=73 Participants
Vehicle ophthalmic solution Vehicle: Proprietary vehicle ophthalmic solution
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 6.64 • n=1512 Participants
|
55.1 years
STANDARD_DEVIATION 6.53 • n=504 Participants
|
53.7 years
STANDARD_DEVIATION 6.46 • n=2016 Participants
|
54.8 years
STANDARD_DEVIATION 6.56 • n=99 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=1512 Participants
|
93 Participants
n=504 Participants
|
54 Participants
n=2016 Participants
|
245 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=1512 Participants
|
51 Participants
n=504 Participants
|
19 Participants
n=2016 Participants
|
116 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=1512 Participants
|
16 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
43 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=1512 Participants
|
128 Participants
n=504 Participants
|
65 Participants
n=2016 Participants
|
318 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=1512 Participants
|
127 Participants
n=504 Participants
|
64 Participants
n=2016 Participants
|
319 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 visits over a total duration of approximately 28 weeksPopulation: One (1) subject was randomized, but not treated due to the enrollment cap being met, resulting in a total of 361 subjects in the Safety Set, comprised of 144 subjects (100.0%) in the LNZ101 treatment group, 144 subjects (100.0%) in the LNZ100 treatment group, and 73/74 subjects (98.6%) in the Vehicle treatment group.
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
Outcome measures
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=144 Participants
LNZ101: Aceclidine + Brimonidine ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=144 Participants
LNZ100: Aceclidine ophthalmic solution Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=73 Participants
Vehicle ophthalmic solution Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Number of Participants With at Least One Treatment-Related TEAE
|
101 Participants
|
75 Participants
|
17 Participants
|
Adverse Events
Aceclidine + Brimonidine (LNZ101)
Serious events: 2 serious events
Other events: 87 other events
Deaths: 1 deaths
Aceclidine Ophthalmic Solution (LNZ100)
Serious events: 2 serious events
Other events: 72 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=144 participants at risk
LNZ101: Aceclidine + Brimonidine ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=144 participants at risk
LNZ100: Aceclidine ophthalmic solution Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=73 participants at risk
Vehicle ophthalmic solution Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Infections and infestations
Non-Ocular Treatment-Emergent Serious Adverse Event
|
0.69%
1/144 • 28 weeks
|
0.00%
0/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
Injury, poisoning and procedural complications
Non-Ocular Treatment-Emergent Serious Adverse Events
|
0.00%
0/144 • 28 weeks
|
0.69%
1/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Ocular Treatment-Emergent Serious Adverse Events
|
0.00%
0/144 • 28 weeks
|
0.69%
1/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
Nervous system disorders
Non-Ocular Treatment-Emergent Serious Adverse Events
|
0.69%
1/144 • 28 weeks
|
0.00%
0/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
Other adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=144 participants at risk
LNZ101: Aceclidine + Brimonidine ophthalmic solution Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=144 participants at risk
LNZ100: Aceclidine ophthalmic solution Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=73 participants at risk
Vehicle ophthalmic solution Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
Visual impairment
|
29.2%
42/144 • 28 weeks
|
19.4%
28/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
Eye disorders
Conjunctival Hyperaemia
|
5.6%
8/144 • 28 weeks
|
11.8%
17/144 • 28 weeks
|
1.4%
1/73 • 28 weeks
|
|
Eye disorders
Ocular Hyperaemia
|
3.5%
5/144 • 28 weeks
|
12.5%
18/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
Eye disorders
Vision Blurred
|
6.2%
9/144 • 28 weeks
|
2.8%
4/144 • 28 weeks
|
9.6%
7/73 • 28 weeks
|
|
Eye disorders
Vitreous Floaters
|
4.9%
7/144 • 28 weeks
|
5.6%
8/144 • 28 weeks
|
0.00%
0/73 • 28 weeks
|
|
General disorders
Instillation Site Irritation
|
24.3%
35/144 • 28 weeks
|
19.4%
28/144 • 28 weeks
|
12.3%
9/73 • 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place