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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

362

Phase

  • 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 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

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
Intervention / Treatment
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

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

LENZ Therapeutics, Inc

Collaborators

ORA, Inc.

Investigators

  • 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)

February 21, 2023

Primary Completion (Actual)

February 9, 2024

Study Completion (Actual)

February 9, 2024

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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