Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

Study Overview
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Brief Summary
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Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

Detailed Description
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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

Official Title
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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

Conditions
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Presbyopia, Near Vision, Miosis, Eye Diseases

Intervention / Treatment
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* Drug: Aceclidine+Brimonidine combination ophthalmic solution
* Drug: Aceclidine ophthalmic solution
* Drug: Placebo (Vehicle) ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be able and willing to provide written informed consent prior to any study procedure being performed; Be able and willing to follow all instructions and attend all study visits; Be 45-75 years of age of either sex at Visit 1; 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; Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1; 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. Be presbyopic as determined at Visit 2 baseline Exclusion Criteria: 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 or their components; 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; Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining; 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;

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNZ101 (Aceclidine/Brimonidine) ophthalmic solution<br>Aceclidine+Brimonidine combination ophthalmic solution | Drug: Aceclidine+Brimonidine combination ophthalmic solution<br>* Aceclidine+Brimonidine combination ophthalmic solution<br>* Other names: LNZ101;|
| Experimental: LNZ100 (Aceclidine) ophthalmic solution<br>Aceclidine ophthalmic solution | Drug: Aceclidine ophthalmic solution<br>* Aceclidine ophthalmic solution<br>* Other names: LNZ100;|
| Placebo Comparator: Placebo (Vehicle) ophthalmic solution<br>Placebo (Vehicle) ophthalmic solution | Drug: Placebo (Vehicle) ophthalmic solution<br>* Placebo (Vehicle) ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected distance visual acuity (BCDVA) at 40 cm | 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) | 3 hours post-treatment in the study eye at Visit 2 (Day 1） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miotic, Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops