Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
- Conditions
- PresbyopiaEye DiseasesRefractive Errors
- Interventions
- Drug: Vehicle Proprietary Ophthalmic Solution
- Registration Number
- NCT05294328
- Lead Sponsor
- LENZ Therapeutics, Inc
- Brief Summary
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
- Detailed Description
The primary efficacy variable in this INSIGHT study is the percentage of subjects with at least a 3-line improvement.
The secondary efficacy variable is the percentage of subjects who achieve a 2-line or greater improvement from pre-treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Combination ophthalmic solution (LNZ101) dosed bilaterally Aceclidine+Brimonidine combination ophthalmic solution LNZ101: Aceclidine/Brimonidine combination ophthalmic solution Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally Aceclidine ophthalmic solution LNZ100: Aceclidine ophthalmic solution Vehicle Ophthalmic Solution dosed bilaterally Vehicle Proprietary Ophthalmic Solution Proprietary Vehicle ophthalmic solution
- Primary Outcome Measures
Name Time Method Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision 1 hour post treatment Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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