Presbyopia, Near Vision, Miosis, Eye Diseases
Conditions
Keywords
Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic
Brief summary
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
Detailed description
A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.
Interventions
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Sponsors
LENZ Therapeutics, Inc
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be able and willing to provide written informed consent 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 at Visit 1; 4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder 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. Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1. 7. Be presbyopic as determined at Visit 2 baseline
Exclusion criteria
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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye; 4. Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining; 5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected distance visual acuity (BCDVA) at 40 cm | 3 hours post-treatment in the study eye at Visit 2 (Day 1） | Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m) |
Countries
China
Outcome results
None listed