What side effects are associated with this type of intervention?

Common treatments for eye diseases, including those similar to LNZ101 for presbyopia, often involve topical medications, oral medications, and surgical interventions. Topical medications can cause local irritation, redness, and systemic effects like respiratory issues. Oral medications may lead to gastrointestinal disturbances and interactions with other drugs. Surgical interventions can result in complications such as infection, inflammation, and changes in vision. For treatments like LNZ101, which are topical, the primary side effects would likely include local irritation and potential systemic absorption effects.

What prior FDA approvals exist?

FDA-approved treatments for eye diseases include a variety of medications and surgical interventions. For conditions like presbyopia, which involves the loss of lens elasticity, treatments have traditionally focused on corrective lenses or surgical options like LASIK. While there are no specific FDA-approved drugs that directly improve lens elasticity, other eye conditions such as glaucoma, uveitis, and dry eye disease have seen approvals for medications like prostaglandin analogs, corticosteroids, and cyclosporine. Research continues into new pharmacologic agents that could potentially address lens accommodation issues, as seen in trials for drugs like LNZ101.

What other types of research exist?

Promising novel alternatives to LNZ101 for improving lens elasticity or accommodation in eye disease patients include: 1) Crystal Evolution® IOLs, which have shown better predictability in postoperative refractive outcomes compared to other IOLs. 2) Sulcoflex piggyback IOLs, which are effective for correcting residual refractive errors post-cataract surgery. 3) Femtosecond laser-assisted cataract surgery (FLACS), which has demonstrated high completion rates and good visual performance in clinical studies.

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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

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new treatment called LNZ101 to help people who have trouble seeing things up close due to aging. The study will compare LNZ101 with another treatment, LNZ100, to see which works best and is safest.

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 myopia and astigmatism in both eyes and be able to follow the study's procedures. Pregnant women, those planning pregnancy, or with severe dry eye, active eye infections, or sensitivity to study drugs cannot join.

What is being tested?

The Phase 3 trial tests LNZ101's safety and effectiveness for treating presbyopia by comparing two combinations: Aceclidine + Brimonidine versus each drug alone (Aceclidine or Brimonidine). The goal is to see which treatment improves near vision without significant side effects.

What are the potential side effects?

Potential side effects may include eye irritation, redness, headache, fatigue, dry mouth or allergic reactions related to Aceclidine or Brimonidine. Specific side effect profiles will be monitored closely throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

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

Treatment Details

Study Objectives

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

Primary study objectives

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Brimonidine ophthalmic solution dosed bilaterallyExperimental Treatment1 Intervention

Brimonidine 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 + Brimonidine

2022

Completed Phase 3

~500

Aceclidine

2023

Completed Phase 3

~790

Brimonidine

2013

Completed Phase 4

~1850

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 and oral antibiotics, glucocorticoids, cyclosporine, and innovative medications like LNZ101. Topical antibiotics, such as azithromycin, work by reducing bacterial load and inflammation, improving symptoms of conditions like blepharitis. Glucocorticoids and cyclosporine reduce inflammation and modulate immune responses, providing relief in severe cases. LNZ101, currently under trial, aims to improve lens elasticity or accommodation, potentially offering a non-surgical solution for presbyopia. Understanding these mechanisms helps patients and doctors choose the most effective treatment, ensuring better management of symptoms and improved quality of life.

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