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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
~710
Aceclidine Ophthalmic Solution
2023
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

LENZ Therapeutics, IncLead Sponsor
8 Previous Clinical Trials
1,189 Total Patients Enrolled
8 Trials studying Presbyopia
1,189 Patients Enrolled for Presbyopia
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,675 Total Patients Enrolled
5 Trials studying Presbyopia
848 Patients Enrolled for Presbyopia
Alisyn Facemire, BAStudy DirectorLENZ Therapeutics
3 Previous Clinical Trials
756 Total Patients Enrolled
3 Trials studying Presbyopia
756 Patients Enrolled for Presbyopia

Media Library

Aceclidine (Cholinergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05753189 — Phase 3
Presbyopia Research Study Groups: Combination ophthalmic solution (LNZ101) dosed bilaterally, Placebo (Vehicle) ophthalmic solution dosed bilaterally, Aceclidine 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially participate in this clinical experiment?

"This trial seeks to enrol 300 participants aged between 45 and 75 years old with presbyopia."

Answered by AI

Are applicants younger than 85 years of age being accepted into this research?

"The prerequisites for this experiment restrict the participants to being between 45 and 75 years of age. Additionally, there are 11 trials available for those below 18 and 117 options for individuals over 65."

Answered by AI

Are any new volunteers being accepted for this research initiative?

"According to the information on clinicaltrials.gov, this medical investigation is actively recruiting participants. The study was first advertised on February 21st 2023 and has since been amended (most recently March 2nd 2023)."

Answered by AI

How many participants have registered for this research endeavor?

"Affirmative. Per clinicaltrials.gov, this research venture is presently searching for volunteers; the study was originally posted on February 21st 2023 and refreshed lastly on March 2nd 2023. 300 people are expected to be enrolled at two distinct centres."

Answered by AI

What side effects have been observed with the bilaterally administered Combination ophthalmic solution (LNZ101)?

"Our organisation has rated Combination ophthalmic solution (LNZ101) dosed bilaterally a 3 on the safety scale due to both efficacy evidence and numerous rounds of data supporting its security."

Answered by AI

Who else is applying?

What site did they apply to?
Site #301
Site #317
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~173 spots leftby Apr 2025