PresbyopiaPhase 3CLARITY 2NCT05728944

Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia

A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by LENZ Therapeutics, Inc at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for the Treatment of Presbyopia Read more about this study

Who is it for?: Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Presbyopia, Near Vision, Refractive Error
What is being tested?: Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 17 sitesUnited States
Study dates: 6 Mar 2023to 24 Jan 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
Be able and willing to follow all instructions and attend all study visits;
Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 1

Who cannot join

Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
Have known contraindications or sensitivity to the use of any of the study medications or their components;
Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Site #215
Bozeman, Montana, 59718
Site #205
Crystal River, Florida, 34429
Site #204
Danbury, Connecticut, 06810
Site #209
Dothan, Alabama, 36301
Site #219
Dover, New Jersey, 07801
Site #213
Eugene, Oregon, 97401
Site #220
Glendale, California, 91204
Site #214
La Jolla, California, 92037
Site #211
Louisville, Kentucky, 40206
Site #203
Newport Beach, California, 92663
Site #218
Northbrook, Illinois, 60062
Site #207
Powell, Ohio, 43065
Site #221
Rochester, New York, 14626
Site #216
Scottsdale, Arizona, 85260
Site #208
St Louis, Missouri, 63128
Site #217
Warwick, Rhode Island, 02888
Site #212
West Fargo, North Dakota, 58078

Other trials in United States

About this study

Official title: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for the Treatment of Presbyopia

Read the detailed description

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Vehicle for the treatment of Presbyopia.

Conditions: Presbyopia, Near Vision, Refractive Error, Eye Diseases
Being tested: Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle
Keywords: Pharmaceutical Solutions, Ophthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
Medical subject headings: Presbyopia, Myopia, Refractive Errors, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aceclidine+Brimonidine combination ophthalmic solutionDrug
Also called LNZ101
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100
Aceclidine ophthalmic solution
VehicleDrug
Proprietary vehicle ophthalmic solution

Study groups in NCT05728944
Study group	Role	What they receive
Aceclidine + Brimonidine (LNZ101) dosed bilaterally	Experimental	LNZ101: Aceclidine + Brimonidine ophthalmic solution Receives: Drug: Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Experimental	LNZ100: Aceclidine ophthalmic solution Receives: Drug: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally	Experimental	Vehicle ophthalmic solution Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1
Measured: 3 hours post-treatment in the study eye on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 202324 Jan 2024

First posted15 Feb 2023
Study start6 Mar 2023
Primary completion14 Dec 2023
Study completion24 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A multi-center, double masked, randomized, controlled, efficacy and safety study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05728944
Sponsor's protocol ID: 22-150-0018
Acronym: CLARITY 2
Status last verified: Oct 2026
First submitted: 6 Feb 2023
Last updated: 29 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
ClinicalTrials.gov ID: NCT05728944
Acronym / sponsor ID: CLARITY 2 / 22-150-0018
Conditions: Presbyopia, Near Vision, Refractive Error, Eye Diseases
Keywords: Pharmaceutical Solutions, Ophthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: LENZ Therapeutics, IncUniversity, hospital or other
Study start: 6 Mar 2023 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 24 Jan 2024 (actual)
First posted: 15 Feb 2023 (actual)
Results: Posted 25 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for the Treatment of Presbyopia

Detailed description

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Vehicle for the treatment of Presbyopia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: A multi-center, double masked, randomized, controlled, efficacy and safety study

Arm	Type	Receives
Aceclidine + Brimonidine (LNZ101) dosed bilaterally	Experimental	Drug: Aceclidine+Brimonidine combination ophthalmic solutionLNZ101: Aceclidine + Brimonidine ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Experimental	Drug: Aceclidine ophthalmic solutionLNZ100: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally	Experimental	Drug: VehicleVehicle ophthalmic solution

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
Be able and willing to follow all instructions and attend all study visits;
Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;

Key exclusion criteria (5 listed)

Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
Have known contraindications or sensitivity to the use of any of the study medications or their components;
Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aceclidine+Brimonidine combination ophthalmic solutionAlso: LNZ101Aceclidine + Brimonidine combination ophthalmic solution	Drug	Aceclidine + Brimonidine (LNZ101) dosed bilaterally
Aceclidine ophthalmic solutionAlso: LNZ100Aceclidine ophthalmic solution	Drug	Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
VehicleProprietary vehicle ophthalmic solution	Drug	Vehicle Ophthalmic Solution dosed bilaterally

Primary outcome

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Time frame: 3 hours post-treatment in the study eye on Day 1
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1

Results and safety

Results posted to the registry on 25 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aceclidine + Brimonidine (LNZ101)	76	68
Aceclidine Ophthalmic Solution (LNZ100)	77	77
Vehicle Ophthalmic Solution	76	75

Primary outcome: Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision

Time frame: 3 hours post-treatment in the study eye on Day 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Aceclidine + Brimonidine (LNZ101) n = 76	Aceclidine Ophthalmic Solution (LNZ100) n = 77	Vehicle Ophthalmic Solution n = 76
Value	57.38 (46.718 to 68.051)	70.59 (60.759 to 80.426)	7.85 (1.978 to 13.716)

Aceclidine + Brimonidine (LNZ101): Odds Ratio (OR): 20.69, p <0.0001, Generalized Estimating Equation (GEE)
Aceclidine Ophthalmic Solution (LNZ100): Odds Ratio (OR): 38.85, p <0.0001, Generalized Estimating Equation (GEE)

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aceclidine + Brimonidine (LNZ101)	0 of 76 (0%)	39 of 76 (51.3%)	0 of 76
Aceclidine Ophthalmic Solution (LNZ100)	0 of 77 (0%)	37 of 77 (48.1%)	0 of 77
Vehicle Ophthalmic Solution	1 of 76 (1.3%)	14 of 76 (18.4%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kris Gambelin, BS study director

LENZ Therapeutics, Inc

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision (time frame: 3 hours post-treatment in the study eye on Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05728944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.