Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Launched by LENZ THERAPEUTICS, INC · Mar 2, 2023

Keywords

ClinConnect Summary

Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. Be able and willing to follow all instructions and attend all study visits;
• • 3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
• • 4. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1;
• • 5. 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
• Exclusion Criteria:
• • 1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
• • 2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
• • 3. 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;
• • 4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
• • 5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1