Overview

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

Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
0
Participant gender:
All
Summary
Phase 3 Efficacy Study to evaluate the Safety and Efficacy 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
Ophthalmic Solutions
Criteria
Inclusion Criteria: Subjects MUST:

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 2 baseline

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 during
dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1
or at Visit 1;