Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects

May 12, 2026 updated by: LENZ Therapeutics, Inc

Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Safety Study of the Long-Term Safety of LNZ100 & LNZ101 in Presbyopic Subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 compared with LNZ100 in Presbyopic Subjects

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Site #326
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Site #302
      • Mesa, Arizona, United States, 85202
        • Site #320
      • Phoenix, Arizona, United States, 85032
        • Site #321
      • Phoenix, Arizona, United States, 85053
        • Site #328
      • Scottsdale, Arizona, United States, 85260
        • Site #338
      • Sun City, Arizona, United States, 85351
        • Site #331
    • California
      • Garden Grove, California, United States, 92843
        • Site #303
      • Glendale, California, United States, 91204
        • Site #313
      • La Jolla, California, United States, 92037
        • Site #334
      • Newport Beach, California, United States, 92663
        • Site #322
      • Petaluma, California, United States, 94954
        • Site #306
      • Rancho Cordova, California, United States, 95670
        • Site #337
      • Santa Barbara, California, United States, 93105
        • Site #304
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Site #308
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Site #316
    • Florida
      • Crystal River, Florida, United States, 34429
        • Site #319
      • Mt. Dora, Florida, United States, 32757
        • Site #309
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Site #339
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Site #340
      • Rock Island, Illinois, United States, 61201
        • Site #317
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Site #301
      • Pittsburg, Kansas, United States, 66762
        • Site #307
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Site #324
    • Minnesota
      • Alexandria, Minnesota, United States, 56308
        • Site #336
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Site #330
      • St Louis, Missouri, United States, 63128
        • Site #325
    • Montana
      • Bozeman, Montana, United States, 59718
        • Site #335
    • New Jersey
      • Dover, New Jersey, United States, 07801
        • Site #341
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Site #310
      • West Fargo, North Dakota, United States, 58078
        • Site #332
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Site #329
      • Powell, Ohio, United States, 43065
        • Site #323
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site #333
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Site #312
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Site #315
      • Smyrna, Tennessee, United States, 37167
        • Site #311
    • Texas
      • El Paso, Texas, United States, 79902
        • Site #314
      • San Antonio, Texas, United States, 78229
        • Site #318
      • San Antonio, Texas, United States, 78229
        • Site #327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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;
  2. Be able and willing to follow all instructions and attend all study visits;
  3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
  4. 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;
  5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
  6. Be presbyopic as determined at Visit 1

Exclusion Criteria:

  1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
  2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
  3. 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;
  4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aceclidine + Brimonidine (LNZ101) dosed bilaterally
LNZ101: Aceclidine + Brimonidine ophthalmic solution
Drug: Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine + Brimonidine combination ophthalmic solution
Other Names:
  • LNZ101
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
LNZ100: Aceclidine ophthalmic solution
Drug: Aceclidine ophthalmic solution
Aceclidine ophthalmic solution
Other Names:
  • LNZ100
Experimental: Vehicle Ophthalmic Solution dosed bilaterally
Vehicle ophthalmic solution
Drug: Vehicle
Vehicle
Other Names:
  • Proprietary vehicle ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment-Related TEAE
Time Frame: 7 visits over a total duration of approximately 28 weeks
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
7 visits over a total duration of approximately 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LENZ Therapeutics, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ORA, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kris Gambelin, BS, LENZ Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-150-0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings