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Cholinergic Agonist

Combination Eye Drops for Presbyopia

Phase 3
Waitlist Available
Research Sponsored by LENZ Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 visits over a total duration of approximately 28 weeks
Awards & highlights

Summary

This trial studied the safety of a drug for long-term use to help with presbyopia (age-related vision problems).

Who is the study for?
This trial is for people aged 45-75 with presbyopia, a condition affecting near vision. Participants must have specific levels of visual acuity (+1.00 to -4.00 diopters) and be willing to follow the study's procedures. Pregnant or nursing women, those planning pregnancy, or individuals with known sensitivities to study medications, active eye infections, severe dry eye, or significant lens abnormalities cannot join.
What is being tested?
The trial tests the long-term safety of LNZ101 in treating presbyopia by comparing an Aceclidine+Brimonidine combination solution against a placebo and Aceclidine alone. The goal is to see if these treatments can safely improve near vision without serious side effects.
What are the potential side effects?
Potential side effects may include reactions at the site of application (eyes), such as redness, discomfort or itching; systemic effects could involve headache or fatigue. Specific side effect profiles will be monitored closely throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 visits over a total duration of approximately 28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 visits over a total duration of approximately 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Objective

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Combination ophthalmic solution (LNZ101) dosed bilaterallyExperimental Treatment1 Intervention
LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution
Group II: Aceclidine ophthalmic solution dosed bilaterallyExperimental Treatment1 Intervention
LNZ 100: Aceclidine ophthalmic solution
Group III: Placebo (Vehicle) ophthalmic solution dosed bilaterallyPlacebo Group1 Intervention
Placebo: Proprietary Vehicle Ophthalmic Solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aceclidine+Brimonidine combination ophthalmic solution
2023
Completed Phase 3
~720
Aceclidine Ophthalmic Solution
2023
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

LENZ Therapeutics, IncLead Sponsor
9 Previous Clinical Trials
1,254 Total Patients Enrolled
9 Trials studying Presbyopia
1,254 Patients Enrolled for Presbyopia
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,598 Total Patients Enrolled
5 Trials studying Presbyopia
855 Patients Enrolled for Presbyopia
Alisyn Facemire, BAStudy DirectorLENZ Therapeutics
4 Previous Clinical Trials
825 Total Patients Enrolled
4 Trials studying Presbyopia
825 Patients Enrolled for Presbyopia

Media Library

Aceclidine (Cholinergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05753189 — Phase 3
Presbyopia Research Study Groups: Aceclidine ophthalmic solution dosed bilaterally, Combination ophthalmic solution (LNZ101) dosed bilaterally, Placebo (Vehicle) ophthalmic solution dosed bilaterally
Presbyopia Clinical Trial 2023: Aceclidine Highlights & Side Effects. Trial Name: NCT05753189 — Phase 3
Aceclidine (Cholinergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753189 — Phase 3
~144 spots leftby Sep 2025
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