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Cholinergic Agonist

Aceclidine + Brimonidine for Presbyopia (CLARITY Trial)

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 3 hours post-treatment in the study eye at visit 2

Awards & highlights

CLARITY Trial Summary

This trial will test a drug to improve near vision in people over 45 with presbyopia.

Who is the study for?

This trial is for people aged 45-75 with presbyopia, a vision condition affecting near sight. Participants must have certain levels of myopia and astigmatism, be willing to consent and attend visits. Pregnant women, those sensitive to study drugs or with active eye infections/inflammation are excluded.Check my eligibility

What is being tested?

The Phase 3 study tests the safety and effectiveness of LNZ101 in treating presbyopia. It compares an aceclidine solution, an aceclidine+brimonidine combination, and a placebo (vehicle) to see which is better at improving near vision.See study design

What are the potential side effects?

Potential side effects may include eye irritation or discomfort, redness, headache or dizziness related to the drops' action on pupil size. Allergic reactions could occur if there's sensitivity to any component.

CLARITY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours post-treatment in the study eye at visit 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours post-treatment in the study eye at visit 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours post-treatment in the study eye at visit 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia.

CLARITY Trial Design

3Treatment groups

Experimental Treatment

Group I: Vehicle Ophthalmic Solution dosed bilaterallyExperimental Treatment1 Intervention

Vehicle ophthalmic solution

Group II: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterallyExperimental Treatment1 Intervention

LNZ100: Aceclidine ophthalmic solution

Group III: Aceclidine + Brimonidine (LNZ101) dosed bilaterallyExperimental Treatment1 Intervention

LNZ101: Aceclidine + Brimonidine ophthalmic solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aceclidine

2023

Completed Phase 3

~790

Aceclidine+Brimonidine combination ophthalmic solution

2023

Completed Phase 3

~710

Vehicle

2013

Completed Phase 3

~5070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LENZ Therapeutics, IncLead Sponsor

8 Previous Clinical Trials

1,321 Total Patients Enrolled

5 Trials studying Eye Diseases

1,222 Patients Enrolled for Eye Diseases

ORA, Inc.Industry Sponsor

69 Previous Clinical Trials

8,723 Total Patients Enrolled

14 Trials studying Eye Diseases

2,753 Patients Enrolled for Eye Diseases

Alisyn Facemire, BAStudy DirectorLENZ Therapeutics

3 Previous Clinical Trials

888 Total Patients Enrolled

3 Trials studying Eye Diseases

888 Patients Enrolled for Eye Diseases

Media Library

Aceclidine (Cholinergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05728944 — Phase 3

Eye Diseases Research Study Groups: Aceclidine + Brimonidine (LNZ101) dosed bilaterally, Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally, Vehicle Ophthalmic Solution dosed bilaterally

Eye Diseases Clinical Trial 2023: Aceclidine Highlights & Side Effects. Trial Name: NCT05728944 — Phase 3

Aceclidine (Cholinergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05728944 — Phase 3

Frequently Asked Questions

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

What criteria must individuals meet to become participants in this research?

"The criteria for participation in this trial requires presbyopia patients aged between 45 to 75. Approximately 222 individuals need to be enrolled into the study."

Answered by AI

Are elderly individuals being sought for enrollment in this investigation?

"For this research protocol, a patient must be aged between 45 and 75. For those under 18 years of age there are 10 studies available, while over 65s can pick from 116 trials."

Answered by AI

Is it currently possible to sign up for this clinical experiment?

"As recorded on clinicaltrials.gov, this medical trial is no longer recruiting participants. After being first posted in March of 2023 and last edited in February of the same year, this study has stopped enrolling volunteers; however, 126 other experiments are currently accepting enrollees."

Answered by AI

What risks and side effects should patients be aware of when taking Aceclidine + Brimonidine (LNZ101) bilaterally?

"The combination of Aceclidine and Brimonidine (LNZ101) is perceived to be safe, as evidenced by its score of 3. The fact that this treatment has reached Phase 3 clinical trials evidences the efficacy it has previously shown, in addition to multiple rounds of data which supports safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia

2023. "Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05728944.

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