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

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: Eye Diseases; Refractive Errors; Presbyopia
• Intervention / Treatment: Drug: Aceclidine+Brimonidine combination ophthalmic solution; Drug: Aceclidine ophthalmic solution; Drug: Vehicle Proprietary Ophthalmic Solution

Detailed Description

The primary efficacy variable in this INSIGHT study is the percentage of subjects with at least a 3-line improvement.

The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater improvement from pre-treatment.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91204
      • INSIGHT-1 Study Site #4
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • INSIGHT-1 Study Site #3
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • INSIGHT-1 Study Site #1
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • INSIGHT-1 Study Site #2
  • Texas
    • Houston, Texas, United States, 77027
      • INSIGHT-1 Study Site #5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects MUST:

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 SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
5. Have up to 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:

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(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 determined by total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally; Aceclidine/Brimonidine combination ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution; Ophthalmic Solution; Other Names: LNZ101; Drug: Aceclidine ophthalmic solution; Ophthalmic Solution; Other Names: LNZ100; Drug: Vehicle Proprietary Ophthalmic Solution; Ophthalmic Solution; Other Names: Vehicle
Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally; Aceclidine ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution; Ophthalmic Solution; Other Names: LNZ101; Drug: Aceclidine ophthalmic solution; Ophthalmic Solution; Other Names: LNZ100; Drug: Vehicle Proprietary Ophthalmic Solution; Ophthalmic Solution; Other Names: Vehicle
Experimental: Vehicle Ophthalmic Solution dosed bilaterally; Proprietary Vehicle ophthalmic solution	Drug: Aceclidine+Brimonidine combination ophthalmic solution; Ophthalmic Solution; Other Names: LNZ101; Drug: Aceclidine ophthalmic solution; Ophthalmic Solution; Other Names: LNZ100; Drug: Vehicle Proprietary Ophthalmic Solution; Ophthalmic Solution; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With at Least a 3-line Improvement in Near Visual Acuity in the Study Eye	The percentage of subjects with at least a 3-line improvement from the pre-dose Aceclidine/Brimonidine (LNZ101) arm versus the vehicle arm, and the Aceclidine arm (LNZ100) versus the vehicle arm.	1 hour

Collaborators and Investigators

• Sponsor: LENZ Therapeutics, Inc
• Collaborators: ORA, Inc.
• Investigators: Study Director: Alisyn Facemire, LENZ Therapeutics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): September 10, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Eye Drops; Near Vision; Pharmaceutical Solutions; Ophthalmic Solutions; INSIGHT; Miotics
• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Presbyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Miotics; Parasympathomimetics; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions; Aceclidine
• Other Study ID Numbers: 21-100-0007

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
• product manufactured in and exported from the U.S.: Yes