Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia (CLARITY 2)

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 LNZ100 & LNZ101 for the Treatment of Presbyopia

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Site #209
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Site #216
  • California
    • Glendale, California, United States, 91204
      • Site #220
    • 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
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Site #218
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Site #211
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Site #208
  • Montana
    • Bozeman, Montana, United States, 59718
      • Site #215
  • New Jersey
    • Dover, New Jersey, United States, 07801
      • Site #219
  • New York
    • Rochester, New York, United States, 14626
      • Site #221
  • North Dakota
    • West 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

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 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 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; 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; Proprietary vehicle 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): March 6, 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): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Eye Drops; Presbyopia; Pharmaceutical Solutions; Ophthalmic Solutions; CLARITY; Miotics
• Additional Relevant MeSH Terms: Refractive Errors; Myopia; Eye Diseases; Presbyopia; Refractive Errors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Pharmaceutical Solutions; Antihypertensive Agents; Parasympathomimetics; Miotics; Brimonidine Tartrate; Ophthalmic Solutions; Aceclidine
• 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