Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia (NCT NCT05431543)

NCT ID: NCT05431543

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: 59 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	18	18	23
Overall Study COMPLETED	17	18	23
Overall Study NOT COMPLETED	1	0	0

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 Medical History	1	0	0

Baseline Characteristics

Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

Baseline characteristics by cohort

Measure	Crossover Sequence 1 (123) n=18 Participants LNZ101 (1), LNZ100 (2), Vehicle (3)	Crossover Sequence 2 (231) n=18 Participants LNZ100 (2), Vehicle (3), LNZ101 (1)	Crossover Sequence 3 (312) n=23 Participants Vehicle (3), LNZ101 (1), LNZ100 (2)	Total n=59 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 6.38 • n=5 Participants	54.7 years STANDARD_DEVIATION 5.55 • n=7 Participants	56 years STANDARD_DEVIATION 7.03 • n=5 Participants	55.2 years STANDARD_DEVIATION 6.34 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	40 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	0 Participants n=5 Participants	1 Participants n=7 Participants	3 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	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (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

PRIMARY outcome

Timeframe: 1 hour post treatment

Population: 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=47 Participants Proprietary vehicle ophthalmic solution
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision	74.0 percentage of participants	75.5 percentage of participants	4.3 percentage of participants

Adverse Events

LNZ101

Serious events: 0 serious events

Other events: 17 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: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LNZ101 n=59 participants at risk LNZ101 (aceclidine hydrochloride and brimonidine tartrate) (non-preserved) Ophthalmic Solution	LNZ100 n=58 participants at risk LNZ100 (Aceclidine hydrochloride) (non-preserved) Ophthalmic solution	Vehicle Ophthalmic Solution n=58 participants at risk Proprietary vehicle ophthalmic solution
General disorders Ocular Instillation Site Pain	6.8% 4/59 • Approximately 3 weeks	5.2% 3/58 • Approximately 3 weeks	0.00% 0/58 • Approximately 3 weeks
General disorders Ocular Instillation Site Pruritus	5.1% 3/59 • Approximately 3 weeks	0.00% 0/58 • Approximately 3 weeks	0.00% 0/58 • Approximately 3 weeks
Nervous system disorders Non-Ocular Headaches	16.9% 10/59 • Approximately 3 weeks	0.00% 0/58 • Approximately 3 weeks	0.00% 0/58 • Approximately 3 weeks

Additional Information

Marc Odrich, MD

LENZ Therapeutics, Inc.

Phone: (646) 249-2800

Email: marc@lenz-tx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place