PresbyopiaPhase 3CLARITY 1NCT05656027
Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution and Brimonidine in people with Presbyopia and Refractive Error, run by LENZ Therapeutics, Inc at 25 sites in United States.
Trial summary
Phase 3 study to evaluate the safety and effectiveness 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, Refractive Error, Eye Diseases
- What is being tested?
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution and Brimonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 25 sitesUnited States
- Study dates
- 19 Dec 2022to 25 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
- Subjects must not:
- 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 in either eye during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Site #130
Azusa, California, 91702
Site #106
Chandler, Arizona, 85224
Site #104
Fargo, North Dakota, 58103
Site #110
Garden Grove, California, 92843
Site #101
Glendale, California, 91204
Site #103
Kingston, Pennsylvania, 18704
Site #109
Littleton, Colorado, 80120
Site #116
Memphis, Tennessee, 38104
Site #121
Mesa, Arizona, 85202
Site #102
Mt. Dora, Florida, 32757
Site #129
Newport Beach, California, 92663
Site #127
Overland Park, Kansas, 66210
Site #107
Petaluma, California, 94954
Site #122
Phoenix, Arizona, 85032
Site #124
Phoenix, Arizona, 85053
Site #108
Pittsburg, Kansas, 66762
Site #126
Rancho Cordova, California, 95670
Site #131
Rochester, New York, 14618
Site #118
Rock Island, Illinois, 61201
Site #119
San Antonio, Texas, 78229
Site #123
San Antonio, Texas, 78229
Site #111
Santa Barbara, California, 93105
Site #128
Scottsdale, Arizona, 85260
Site #112
Smyrna, Tennessee, 37167
Site #125
Sun City, Arizona, 85351
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 study to evaluate the safety and effectiveness 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 Brimonidine for the treatment of Presbyopia.
- Conditions
- Presbyopia, Refractive Error, Eye Diseases, Near Vision
- Being tested
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Brimonidine
- Keywords
- Pharmaceutical Solutions, Eye Drops, CLARITY, Presbyopia, Ophthalmic Solutions, Miotics
- Medical subject headings
- Presbyopia, Refractive Errors, Eye Diseases, Myopia
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
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100
LNZ100 Aceclidine ophthalmic solution
BrimonidineDrug
Brimonidine ophthalmic solution
| 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 |
| Brimonidine ophthalmic solution dosed bilaterally | Experimental | Brimonidine ophthalmic solution Receives: Drug: Brimonidine |
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.
- First posted19 Dec 2022
- Study start19 Dec 2022
- Primary completion15 Dec 2023
- Study completion25 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, active-controlled, safety and efficacy study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris Gambelin, BS, Study director, LENZ Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656027
- Sponsor's protocol ID
- 22-150-0015
- Acronym
- CLARITY 1
- Status last verified
- May 2026
- First submitted
- 9 Dec 2022
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 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
- NCT05656027
- Acronym / sponsor ID
- CLARITY 1 / 22-150-0015
- Conditions
- Presbyopia, Refractive Error, Eye Diseases, Near Vision
- Keywords
- Pharmaceutical Solutions, Eye Drops, CLARITY, Presbyopia, Ophthalmic Solutions, Miotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- LENZ Therapeutics, IncUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 19 Dec 2022 (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 study to evaluate the safety and effectiveness 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 Brimonidine 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, active-controlled, safety and efficacy 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 |
| Brimonidine ophthalmic solution dosed bilaterally | Experimental | Drug: BrimonidineBrimonidine 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 (6 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 in either eye 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: LNZ101LNZ101 (Aceclidine/Brimonidine) ophthalmic solution | Drug | Aceclidine + Brimonidine (LNZ101) dosed bilaterally |
| Aceclidine ophthalmic solutionAlso: LNZ100LNZ100 Aceclidine ophthalmic solution | Drug | Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally |
| BrimonidineBrimonidine ophthalmic solution | Drug | Brimonidine 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution and Brimonidine in people with Presbyopia and Refractive Error, run by LENZ Therapeutics, Inc at 25 sites in United States.
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 6 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
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 13 May 2026.