Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (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.

Completed

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Key information

Conditions

Presbyopia Eye Diseases Myopia Refractive Errors

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

INSIGHT-2 Study Site #5, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 +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;
Have ≤ 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 1

Exclusion criteria

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 defined as total corneal fluorescein staining at Visit 1;
Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1

Treatment and study plan

Aceclidine+Brimonidine combination ophthalmic solution

Drug

LNZ101-combination ophthalmic solution

Other names: LNZ101, Brimonidine and Aceclidine

Aceclidine ophthalmic solution

Drug

LNZ100- aceclidine ophthalmic solution

Other names: LNZ100, Aceclidine

Vehicle proprietary ophthalmic solution

Drug

Proprietary Vehicle ophthalmic solution

Other names: Vehicle

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

LENZ Therapeutics, Inc

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 24, 2022
Registry last updated: Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed