Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia

August 14, 2024 updated by: LENZ Therapeutics, Inc

A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

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
    • Arizona
      • Chandler, Arizona, United States, 85224
        • INSIGHT-2 Study Site #5
    • California
      • Glendale, California, United States, 91204
        • INSIGHT-2 Study Site #3
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • INSIGHT-2 Study Site #1
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • INSIGHT-2 Study Site #2
    • Texas
      • Houston, Texas, United States, 77027
        • INSIGHT-2 Study Site #4

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 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 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 (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
  5. Have ≤ 2.00D 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(s) or their components;
  3. Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
  4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
  5. Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of 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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vehicle Ophthalmic Solution dosed bilaterally
Proprietary vehicle ophthalmic solution
Drug: Vehicle proprietary ophthalmic solution
Proprietary Vehicle ophthalmic solution
Other Names:
  • Vehicle
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally
LNZ 101: Aceclidine/Brimonidine combination ophthalmic solution
Drug: Aceclidine+Brimonidine combination ophthalmic solution
LNZ101-combination ophthalmic solution
Other Names:
  • LNZ101
  • Brimonidine and Aceclidine
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
LNZ 100: Aceclidine ophthalmic solution
Drug: Aceclidine ophthalmic solution
LNZ100- aceclidine ophthalmic solution
Other Names:
  • Aceclidine
  • LNZ100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Time Frame: 1 hour post treatment
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
1 hour post treatment

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)

August 6, 2022

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-100-0003

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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