Trial Outcomes & Findings for Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia (NCT NCT05656027)
NCT ID: NCT05656027
Last Updated: 2026-05-13
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
469 participants
Primary outcome timeframe
3 hours post-treatment in the study eye on Day 1
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Aceclidine + Brimonidine (LNZ101)
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
156
|
157
|
156
|
|
Overall Study
COMPLETED
|
144
|
150
|
148
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
8
|
Reasons for withdrawal
| Measure |
Aceclidine + Brimonidine (LNZ101)
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
5
|
|
Overall Study
Left after Installation
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
|
Overall Study
Prohibited medication used during study participation
|
0
|
1
|
0
|
Baseline Characteristics
Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
Baseline characteristics by cohort
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=156 Participants
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=157 Participants
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
n=156 Participants
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
Total
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 6.55 • n=1512 Participants
|
55.3 years
STANDARD_DEVIATION 6.07 • n=504 Participants
|
54.9 years
STANDARD_DEVIATION 6.45 • n=2016 Participants
|
55.5 years
STANDARD_DEVIATION 6.37 • n=99 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=1512 Participants
|
109 Participants
n=504 Participants
|
99 Participants
n=2016 Participants
|
307 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=1512 Participants
|
48 Participants
n=504 Participants
|
57 Participants
n=2016 Participants
|
162 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=1512 Participants
|
36 Participants
n=504 Participants
|
47 Participants
n=2016 Participants
|
138 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=1512 Participants
|
121 Participants
n=504 Participants
|
109 Participants
n=2016 Participants
|
331 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
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
10 Participants
n=2016 Participants
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=1512 Participants
|
138 Participants
n=504 Participants
|
135 Participants
n=2016 Participants
|
407 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
3 Participants
n=99 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=156 Participants
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=157 Participants
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
n=156 Participants
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
|
48.68 percentage of participants
Interval 40.823 to 56.547
|
64.5 percentage of participants
Interval 57.076 to 71.92
|
11.49 percentage of participants
Interval 6.515 to 16.464
|
Adverse Events
Aceclidine + Brimonidine (LNZ101)
Serious events: 3 serious events
Other events: 73 other events
Deaths: 0 deaths
Aceclidine Ophthalmic Solution (LNZ100)
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Brimonidine Ophthalmic Solution
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=156 participants at risk
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=157 participants at risk
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
n=156 participants at risk
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Non-Ocular Treatment-Emergent Serious Adverse Event
|
0.64%
1/156 • Number of events 1 • 6 weeks
|
0.00%
0/157 • 6 weeks
|
0.00%
0/156 • 6 weeks
|
|
Eye disorders
Ocular Treatment-Emergent Serious Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 weeks
|
0.00%
0/157 • 6 weeks
|
0.00%
0/156 • 6 weeks
|
|
Injury, poisoning and procedural complications
Non-Ocular Treatment-Emergent Serious Adverse Event
|
0.64%
1/156 • Number of events 1 • 6 weeks
|
0.00%
0/157 • 6 weeks
|
0.00%
0/156 • 6 weeks
|
Other adverse events
| Measure |
Aceclidine + Brimonidine (LNZ101)
n=156 participants at risk
LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine + Brimonidine: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
|
Aceclidine Ophthalmic Solution (LNZ100)
n=157 participants at risk
LNZ100 (Aceclidine) ophthalmic solution
Aceclidine: LNZ100 Aceclidine ophthalmic solution
|
Brimonidine Ophthalmic Solution
n=156 participants at risk
Brimonidine ophthalmic solution
Brimonidine: Brimonidine ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
Visual Impairment
|
17.9%
28/156 • 6 weeks
|
10.2%
16/157 • 6 weeks
|
0.00%
0/156 • 6 weeks
|
|
Eye disorders
Vision blurred
|
3.8%
6/156 • 6 weeks
|
3.2%
5/157 • 6 weeks
|
9.6%
15/156 • 6 weeks
|
|
Eye disorders
Ocular Hyperaemia
|
5.1%
8/156 • 6 weeks
|
4.5%
7/157 • 6 weeks
|
0.00%
0/156 • 6 weeks
|
|
General disorders
Instillation Site Irritation
|
19.9%
31/156 • 6 weeks
|
19.1%
30/157 • 6 weeks
|
6.4%
10/156 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place