Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
Completed · Phase 2
Conditions studied: Presbyopia, Refractive Errors, Eye Diseases
In brief
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
Key facts
- Study ID
- NCT05294328
- Run by
- LENZ Therapeutics, Inc
- People needed
- 68
- Starts
- 2022-05-05
- Expected to finish
- 2022-09-10
- Last updated by the study team
- 2024-09-05
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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;
Where it is running
- INSIGHT-1 Study Site #4 — Glendale, California, United States
- INSIGHT-1 Study Site #3 — Indianapolis, Indiana, United States
- INSIGHT-1 Study Site #1 — Andover, Massachusetts, United States
- INSIGHT-1 Study Site #2 — Memphis, Tennessee, United States
- INSIGHT-1 Study Site #5 — Houston, Texas, United States
Full record on ClinicalTrials.gov
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