What is the mechanism of action of this treatment?

Common treatments for eye diseases include topical antibiotics, glucocorticoids, cyclosporine, and pharmacological agents like LNZ101. Topical antibiotics reduce bacterial load, glucocorticoids decrease inflammation, and cyclosporine modulates immune responses. LNZ101, likely a pharmacological agent, may improve lens flexibility or affect ciliary muscles, enhancing accommodation and vision. Understanding these mechanisms helps patients and doctors choose the most effective treatment, manage side effects, and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for eye diseases, particularly those affecting lens flexibility or ciliary muscles, include various pharmacological agents such as prostaglandin analogs, beta-blockers, and cholinergic agonists. Prostaglandin analogs can cause side effects like eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to respiratory issues, bradycardia, and hypotension. Cholinergic agonists, such as pilocarpine, can cause headaches, brow ache, and reduced night vision. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several pharmacological agents for the treatment of eye diseases. For glaucoma, medications such as beta-adrenergic antagonists (e.g., timolol) and alpha2-adrenergic agonists (e.g., brimonidine) are used to lower intraocular pressure. For dry eye disease, treatments include cyclosporine drops and loteprednol etabonate, which reduce inflammation and improve tear production. While specific drugs that improve lens flexibility or affect ciliary muscles are not detailed in the provided context, these examples illustrate the range of pharmacological treatments available for various ocular conditions.

What other types of research exist?

Promising novel alternatives to LNZ101 for eye diseases include: 1) Latanoprostene bunod, a nitric oxide-donating prostaglandin F2α receptor agonist, which has shown efficacy in lowering intraocular pressure in glaucoma patients. 2) UF-021, a novel prostaglandin metabolite-related compound, which has demonstrated significant intraocular pressure reduction without side effects in clinical trials. 3) Cyclohexyladenosine (CHA), an adenosine A(1) agonist, which has been studied for its effects on intraocular pressure and pupil diameter. These agents represent potential advancements in the treatment of eye diseases by targeting different mechanisms involved in ocular health.

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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for eye diseases include topical antibiotics, glucocorticoids, cyclosporine, and pharmacological agents like LNZ101. Topical antibiotics reduce bacterial load, glucocorticoids decrease inflammation, and cyclosporine modulates immune responses. LNZ101, likely a pharmacological agent, may improve lens flexibility or affect ciliary muscles, enhancing accommodation and vision. Understanding these mechanisms helps patients and doctors choose the most effective treatment, manage side effects, and improve quality of life.

Non-drug interventions in glaucoma: Putative roles for lifestyle, diet and nutritional supplements.Marihuana-derived material: biochemical studies of the ocular responses.Open-angle glaucoma: therapeutically targeting the extracellular matrix of the conventional outflow pathway.

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

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