Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects

Completed · Phase 3

Conditions studied: Presbyopia, Near Vision, Refractive Error, Eye Diseases

In brief

Safety Study of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects

Key facts

Study ID

NCT05753189

Run by

LENZ Therapeutics, Inc

People needed

362

Starts

2023-02-21

Expected to finish

2024-02-09

Last updated by the study team

2026-05-13

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;
• Be able and willing to follow all instructions and attend all 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 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;
• Have ≤2.00 D 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…

• 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 or their components;
• 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;
• Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
• 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

Where it is running

• Site #326 — Dothan, Alabama, United States
• Site #302 — Chandler, Arizona, United States
• Site #320 — Mesa, Arizona, United States
• Site #321 — Phoenix, Arizona, United States
• Site #328 — Phoenix, Arizona, United States
• Site #338 — Scottsdale, Arizona, United States
• Site #331 — Sun City, Arizona, United States
• Site #303 — Garden Grove, California, United States
• Site #313 — Glendale, California, United States
• Site #334 — La Jolla, California, United States
• Site #322 — Newport Beach, California, United States
• Site #306 — Petaluma, California, United States
• Site #337 — Rancho Cordova, California, United States
• Site #304 — Santa Barbara, California, United States
• Site #308 — Littleton, Colorado, United States
• Site #316 — Danbury, Connecticut, United States
• Site #319 — Crystal River, Florida, United States
• Site #309 — Mt. Dora, Florida, United States
• Site #339 — Morrow, Georgia, United States
• Site #340 — Northbrook, Illinois, United States
• Site #317 — Rock Island, Illinois, United States
• Site #301 — Overland Park, Kansas, United States
• Site #307 — Pittsburg, Kansas, United States
• Site #324 — Louisville, Kentucky, United States
• Site #336 — Alexandria, Minnesota, United States

Full record on ClinicalTrials.gov

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