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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

CLARITY Trial Summary

This trial tests a new drug to treat age-related vision loss, to see if it's safe and effective.

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.Check my eligibility
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.See study design
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.

CLARITY Trial Timeline

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

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

CLARITY 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

Find a Location

Who is running the clinical trial?

LENZ Therapeutics, IncLead Sponsor
8 Previous Clinical Trials
1,081 Total Patients Enrolled
5 Trials studying Eye Diseases
982 Patients Enrolled for Eye Diseases
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,567 Total Patients Enrolled
14 Trials studying Eye Diseases
2,513 Patients Enrolled for Eye Diseases
Alisyn Facemire, BAStudy DirectorLENZ Therapeutics
3 Previous Clinical Trials
648 Total Patients Enrolled
3 Trials studying Eye Diseases
648 Patients Enrolled for Eye Diseases

Media Library

LNZ101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05656027 — Phase 3
Eye Diseases Research Study Groups: Aceclidine + Brimonidine (LNZ101) dosed bilaterally, Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally, Brimonidine ophthalmic solution dosed bilaterally
Eye Diseases Clinical Trial 2023: LNZ101 Highlights & Side Effects. Trial Name: NCT05656027 — Phase 3
LNZ101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656027 — Phase 3

Frequently Asked Questions

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

Does this investigation provide the opportunity for individuals over 35 to participate?

"This clinical trial will accept participants between 45 and 75 years old. There are 22 trials for those below 18, and 128 studies related to people over 65."

Answered by AI

Is the clinical investigation actively seeking participants at this time?

"According to the clinicaltrials.gov page, this research initiative is actively recruiting patients. It was initially announced on December 19th 2022 and last revised on December 9th 2022."

Answered by AI

How many volunteers are currently participating in this clinical investigation?

"Affirmative. The clinicaltrial.gov listing confirms that this medical trial is actively enrolling, having been initially posted on December 19th 2022 and recently updated on December 9th 2022. This research requires 435 participants from 1 site to be recruited."

Answered by AI

What potential risks are associated with Aceclidine Ophthalmic Solution (LNZ100) when administered in both eyes of a patient?

"Considering the data provided by our team at Power, Aceclidine Ophthalmic Solution (LNZ100) received a score of 3 due to its Phase 3 status. This implies that there is sufficient evidence surrounding both safety and efficacy."

Answered by AI

Which demographic of individuals is most suitable for participating in this research?

"This medical trial requires 435 individuals between the ages of 45 and 75, who have been diagnosed with presbyopia. Furthermore, these participants must be willing to provide written informed consent, comply with instructions from their doctor or research team members, pass a refraction test at Visit 1 (with no more than -4 D MRSE in both eyes), not exceed 2 D cylinder for either eye during this testing, and verify that they are indeed presbyopic by the end of Visit 1."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Site #101
Site #110
Site #118
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
2022. "Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656027.
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~201 spots leftby Apr 2025
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