Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia (CLARITY 1)

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Refractive Error; Presbyopia; Near Vision
• Intervention / Treatment: Drug: Brimonidine; Drug: Aceclidine+Brimonidine combination ophthalmic solution; Drug: Aceclidine ophthalmic solution

Detailed Description

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.

• Study Type: Interventional
• Enrollment (Actual): 469
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Site #106
    • Mesa, Arizona, United States, 85202
      • Site #121
    • Phoenix, Arizona, United States, 85032
      • Site #122
    • Phoenix, Arizona, United States, 85053
      • Site #124
    • Scottsdale, Arizona, United States, 85260
      • Site #128
    • Sun City, Arizona, United States, 85351
      • Site #125
  • California
    • Azusa, California, United States, 91702
      • Site #130
    • Garden Grove, California, United States, 92843
      • Site #110
    • Glendale, California, United States, 91204
      • Site #101
    • Newport Beach, California, United States, 92663
      • Site #129
    • Petaluma, California, United States, 94954
      • Site #107
    • Rancho Cordova, California, United States, 95670
      • Site #126
    • Santa Barbara, California, United States, 93105
      • Site #111
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Site #109
  • Florida
    • Mt. Dora, Florida, United States, 32757
      • Site #102
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Site #118
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Site #127
    • Pittsburg, Kansas, United States, 66762
      • Site #108
  • New York
    • Rochester, New York, United States, 14618
      • Site #131
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Site #104
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Site #103
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Site #116
    • Smyrna, Tennessee, United States, 37167
      • Site #112
  • Texas
    • San Antonio, Texas, United States, 78229
      • Site #119
    • San Antonio, Texas, United States, 78229
      • Site #123

Participation Criteria

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:

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 in either eye during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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; LNZ101 (Aceclidine/Brimonidine) ophthalmic solution; Other Names: LNZ101
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally; LNZ100 (Aceclidine) ophthalmic solution	Drug: Aceclidine ophthalmic solution; LNZ100 Aceclidine ophthalmic solution; Other Names: LNZ100
Experimental: Brimonidine ophthalmic solution dosed bilaterally; Brimonidine ophthalmic solution	Drug: Brimonidine; Brimonidine ophthalmic solution

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	Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1	3 hours post-treatment in the study eye on Day 1

Collaborators and Investigators

• Sponsor: LENZ Therapeutics, Inc
• Collaborators: ORA, Inc.
• Investigators: Study Director: Kris Gambelin, BS, LENZ Therapeutics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

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: Eye Drops; Presbyopia; Pharmaceutical Solutions; Ophthalmic Solutions; CLARITY; Miotics
• Additional Relevant MeSH Terms: Myopia; Eye Diseases; Presbyopia; Refractive Errors; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Brimonidine Tartrate
• Other Study ID Numbers: 22-150-0015

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