Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia

Completed · Phase 3

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

In brief

Phase 3 study to evaluate the safety and effectiveness of LNZ100 \& LNZ101 for the treatment of Presbyopia.

Key facts

Study ID

NCT05656027

Run by

LENZ Therapeutics, Inc

People needed

469

Starts

2022-12-19

Expected to finish

2024-01-25

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…

• 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 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 in either eye during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;

Where it is running

• Site #106 — Chandler, Arizona, United States
• Site #121 — Mesa, Arizona, United States
• Site #122 — Phoenix, Arizona, United States
• Site #124 — Phoenix, Arizona, United States
• Site #128 — Scottsdale, Arizona, United States
• Site #125 — Sun City, Arizona, United States
• Site #130 — Azusa, California, United States
• Site #110 — Garden Grove, California, United States
• Site #101 — Glendale, California, United States
• Site #129 — Newport Beach, California, United States
• Site #107 — Petaluma, California, United States
• Site #126 — Rancho Cordova, California, United States
• Site #111 — Santa Barbara, California, United States
• Site #109 — Littleton, Colorado, United States
• Site #102 — Mt. Dora, Florida, United States
• Site #118 — Rock Island, Illinois, United States
• Site #127 — Overland Park, Kansas, United States
• Site #108 — Pittsburg, Kansas, United States
• Site #131 — Rochester, New York, United States
• Site #104 — Fargo, North Dakota, United States
• Site #103 — Kingston, Pennsylvania, United States
• Site #116 — Memphis, Tennessee, United States
• Site #112 — Smyrna, Tennessee, United States
• Site #119 — San Antonio, Texas, United States
• Site #123 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.