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

NCT05294328 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 21-100-0007
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Presbyopia; Refractive Errors; Eye Diseases

Keywords

Pharmaceutical Solutions; Miotics; Ophthalmic Solutions; Near Vision; Eye Drops; INSIGHT 1

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour post treatment

Study Arms (3)

Combination ophthalmic solution (LNZ101) dosed bilaterally

EXPERIMENTAL

LNZ101: Aceclidine/Brimonidine combination ophthalmic solution

Drug: Aceclidine+Brimonidine combination ophthalmic solution

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

EXPERIMENTAL

LNZ100: Aceclidine ophthalmic solution

Drug: Aceclidine ophthalmic solution

Vehicle Ophthalmic Solution dosed bilaterally

EXPERIMENTAL

Proprietary Vehicle ophthalmic solution

Drug: Vehicle Proprietary Ophthalmic Solution

Interventions

Aceclidine+Brimonidine combination ophthalmic solution DRUG

LNZ101-combination ophthalmic solution

Also known as: LNZ101, Brimonidine and Aceclidine

Combination ophthalmic solution (LNZ101) dosed bilaterally

Aceclidine ophthalmic solution DRUG

LNZ100- aceclidine ophthalmic solution

Also known as: LNZ100, Aceclidine

Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally

Vehicle Proprietary Ophthalmic Solution DRUG

Proprietary Vehicle Ophthalmic Solution

Also known as: Vehicle

Vehicle Ophthalmic Solution dosed bilaterally

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST:
• 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;
• Be able and willing to follow all instructions and attend study visits;
• Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
• Have up to 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
• Be presbyopic as determined at Visit 1

You may not qualify if:

• Subjects must NOT:
• Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
• Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
• 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;
• Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
• 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;

Sponsors & Collaborators

• LENZ Therapeutics, Inc: lead

Study Sites (5)

INSIGHT-1 Study Site #4

Glendale, California, 91204, United States

Location

INSIGHT-1 Study Site #3

Indianapolis, Indiana, 46240, United States

Location

INSIGHT-1 Study Site #1

Andover, Massachusetts, 01810, United States

Location

INSIGHT-1 Study Site #2

Memphis, Tennessee, 38119, United States

Location

INSIGHT-1 Study Site #5

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Presbyopia; Refractive Errors; Eye Diseases; Myopia

Interventions

Brimonidine Tartrate; aceclidine

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Marc Odrich, MD
• Organization: LENZ Therapeutics, Inc.

marc@lenz-tx.com

(646) 249-2800

Study Officials

• Alisyn Facemire, BA

  LENZ Therapeutics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 24, 2022
• Study Start: May 5, 2022
• Primary Completion: August 22, 2022
• Study Completion: September 10, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)