Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

Detailed Description
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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.

Official Title
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A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

Conditions
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Presbyopia, Refractive Errors, Eye Diseases

Intervention / Treatment
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* Drug: Aceclidine+Brimonidine combination ophthalmic solution
* Drug: Aceclidine ophthalmic solution
* Drug: Vehicle Proprietary Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally<br>Aceclidine/Brimonidine combination ophthalmic solution | Drug: Aceclidine+Brimonidine combination ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ101;Drug: Aceclidine ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ100;Drug: Vehicle Proprietary Ophthalmic Solution<br>* Ophthalmic Solution<br>* Other names: Vehicle;|
| Experimental: Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally<br>Aceclidine ophthalmic solution | Drug: Aceclidine+Brimonidine combination ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ101;Drug: Aceclidine ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ100;Drug: Vehicle Proprietary Ophthalmic Solution<br>* Ophthalmic Solution<br>* Other names: Vehicle;|
| Experimental: Vehicle Ophthalmic Solution dosed bilaterally<br>Proprietary Vehicle ophthalmic solution | Drug: Aceclidine+Brimonidine combination ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ101;Drug: Aceclidine ophthalmic solution<br>* Ophthalmic Solution<br>* Other names: LNZ100;Drug: Vehicle Proprietary Ophthalmic Solution<br>* Ophthalmic Solution<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With at Least a 3-line Improvement in Near Visual Acuity in the Study Eye | The percentage of subjects with at least a 3-line improvement from the pre-dose Aceclidine/Brimonidine (LNZ101) arm versus the vehicle arm, and the Aceclidine arm (LNZ100) versus the vehicle arm. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miotics, Pharmaceutical Solutions, Ophthalmic Solutions, Near Vision, Eye Drops, INSIGHT