Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia (CLARITY)

January 30, 2024 updated by: LENZ Therapeutics, Inc

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 LNZ101 for the Treatment of Presbyopia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

229

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Site #209
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Site #216
    • California
      • La Jolla, California, United States, 92037
        • Site #214
      • Newport Beach, California, United States, 92663
        • Site #203
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Site #204
    • Florida
      • Crystal River, Florida, United States, 34429
        • Site #205
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Site #211
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Site #208
    • Montana
      • Bozeman, Montana, United States, 59718
        • Site #215
    • North Dakota
      • W. Fargo, North Dakota, United States, 58078
        • Site #212
    • Ohio
      • Powell, Ohio, United States, 43065
        • Site #207
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site #213
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Site #217

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: Subjects MUST:

  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 2 baseline

Exclusion Criteria: Subjects must NOT:

  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: Quadruple

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
Aceclidine ophthalmic solution
Other Names:
  • LNZ100
Experimental: Vehicle Ophthalmic Solution dosed bilaterally
Vehicle ophthalmic solution
Drug: Vehicle
Proprietary vehicle ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia.
Time Frame: 3 hours post-treatment in the study eye at Visit 2

Percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye.

compared with vehicle for the treatment of Presbyopia.
3 hours post-treatment in the study eye at Visit 2

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: Alisyn Facemire, BA, LENZ Therapeutics

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)

April 24, 2023

Primary Completion (Actual)

December 14, 2023

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-150-0018

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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