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

• Status: Recruiting
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LENZ Therapeutics, Inc
• Collaborator: ORA, Inc.
• Treatments: Aceclidine; Brimonidine Tartrate

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. 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;

5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;

6. Be presbyopic as determined at Visit 1

Exclusion Criteria:

Subjects must not:

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 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;

4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;

5. 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;