CompletedPhase 3

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

United States469 participantsStarted 2022-12-19

Plain-language summary

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

Age range45 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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;

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision

Timeframe: 3 hours post-treatment in the study eye on Day 1

NCT IDNCT05656027

SponsorLENZ Therapeutics, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

Results submitted2026-02-05

Who can participate

Age range45 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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;