Status:
COMPLETED
Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Lead Sponsor:
LENZ Therapeutics, Inc
Conditions:
Presbyopia
Refractive Errors
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
Eligibility Criteria
Inclusion
- Subjects MUST:
- Be able and willing to provide written informed consent and sign 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 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 (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
- Have up to 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- Be presbyopic as determined at Visit 1
Exclusion
- Subjects must NOT:
- 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(s) 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
- Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
- Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05294328
Start Date
May 5 2022
End Date
September 10 2022
Last Update
September 5 2024
Active Locations (5)
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1
INSIGHT-1 Study Site #4
Glendale, California, United States, 91204
2
INSIGHT-1 Study Site #3
Indianapolis, Indiana, United States, 46240
3
INSIGHT-1 Study Site #1
Andover, Massachusetts, United States, 01810
4
INSIGHT-1 Study Site #2
Memphis, Tennessee, United States, 38119