CompletedPhase 3

Phase 3 Safety Study for the Treatment of Presbyopia Subjects

United States362 participantsStarted 2023-02-21

Plain-language summary

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Age range45 Years – 75 Years

SexALL

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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;
✓. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
✓. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented 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 (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 corneal fluorescein staining at Visit 1;
✕. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

Primary Objective

Timeframe: 7 visits over a total duration of approximately 28 weeks

NCT IDNCT05753189

SponsorLENZ Therapeutics, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-09