Trial Outcomes & Findings for Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia (NCT NCT05728944)
NCT ID: NCT05728944
Last Updated: 2026-02-25
Results Overview
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
229 participants
Primary outcome timeframe
3 hours post-treatment in the study eye on Day 1
Results posted on
2026-02-25
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
|
76
|
77
|
76
|
|
Overall Study
COMPLETED
|
68
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia
Baseline characteristics by cohort
| Measure |
Aceclidine Ophthalmic Solution (LNZ100)
n=77 Participants
LNZ100: Aceclidine ophthalmic solution
Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=76 Participants
Vehicle ophthalmic solution
Vehicle: Proprietary vehicle ophthalmic solution
|
Total
n=229 Participants
Total of all reporting groups
|
Aceclidine + Brimonidine (LNZ101)
n=76 Participants
LNZ101: Aceclidine + Brimonidine ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 5.4 • n=20 Participants
|
53.6 years
STANDARD_DEVIATION 4.93 • n=40 Participants
|
54.4 years
STANDARD_DEVIATION 5.45 • n=565 Participants
|
54.8 years
STANDARD_DEVIATION 5.96 • n=24 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=20 Participants
|
46 Participants
n=40 Participants
|
149 Participants
n=565 Participants
|
51 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
80 Participants
n=565 Participants
|
25 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
34 Participants
n=565 Participants
|
14 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
195 Participants
n=565 Participants
|
62 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=565 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=565 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=565 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=565 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
208 Participants
n=565 Participants
|
69 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=565 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 3 hours post-treatment in the study eye on Day 1Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1
Outcome measures
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=76 Participants
LNZ101: Aceclidine + Brimonidine ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=77 Participants
LNZ100: Aceclidine ophthalmic solution
Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=76 Participants
Vehicle ophthalmic solution
Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
|
57.38 percentage of participants
Interval 46.718 to 68.051
|
70.59 percentage of participants
Interval 60.759 to 80.426
|
7.85 percentage of participants
Interval 1.978 to 13.716
|
Adverse Events
Aceclidine + Brimonidine (LNZ101)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Aceclidine Ophthalmic Solution (LNZ100)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=76 participants at risk
LNZ101: Aceclidine + Brimonidine ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=77 participants at risk
LNZ100: Aceclidine ophthalmic solution
Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=76 participants at risk
Vehicle ophthalmic solution
Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
General disorders
Non-Ocular Treatment-Emergent Serious Adverse Events
|
0.00%
0/76 • 6 weeks
|
0.00%
0/77 • 6 weeks
|
1.3%
1/76 • 6 weeks
|
Other adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=76 participants at risk
LNZ101: Aceclidine + Brimonidine ophthalmic solution
Aceclidine+Brimonidine combination ophthalmic solution: Aceclidine + Brimonidine combination ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=77 participants at risk
LNZ100: Aceclidine ophthalmic solution
Aceclidine: Aceclidine ophthalmic solution
|
Vehicle Ophthalmic Solution
n=76 participants at risk
Vehicle ophthalmic solution
Vehicle: Proprietary vehicle ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
Visual Impairment
|
17.1%
13/76 • 6 weeks
|
19.5%
15/77 • 6 weeks
|
1.3%
1/76 • 6 weeks
|
|
Eye disorders
Vision Blurred
|
6.6%
5/76 • 6 weeks
|
6.5%
5/77 • 6 weeks
|
2.6%
2/76 • 6 weeks
|
|
Eye disorders
Vitreous Floaters
|
7.9%
6/76 • 6 weeks
|
6.5%
5/77 • 6 weeks
|
1.3%
1/76 • 6 weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
1.3%
1/76 • 6 weeks
|
11.7%
9/77 • 6 weeks
|
1.3%
1/76 • 6 weeks
|
|
Eye disorders
Eye Irritation
|
0.00%
0/76 • 6 weeks
|
5.2%
4/77 • 6 weeks
|
0.00%
0/76 • 6 weeks
|
|
General disorders
Instillation site irritation
|
26.3%
20/76 • 6 weeks
|
22.1%
17/77 • 6 weeks
|
10.5%
8/76 • 6 weeks
|
|
Eye disorders
Punctate Keratitis
|
5.3%
4/76 • 6 weeks
|
2.6%
2/77 • 6 weeks
|
1.3%
1/76 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place