Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Study Overview
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Brief Summary
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Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Detailed Description
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Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Official Title
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Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

Conditions
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Presbyopia, Near Vision, Miosis, Eye Diseases

Intervention / Treatment
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* Drug: Aceclidine+Brimonidine combination ophthalmic solution
* Drug: Placebo
* Drug: Aceclidine 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 and sign a 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 all study visits; Be 45-75 years of age of either sex and any race or ethnicity at Visit 1; Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1 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 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye; Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam 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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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: Parallel Assignment
Interventional Model Description: A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination ophthalmic solution (LNZ101) dosed bilaterally<br>LNZ 101: Aceclidine/Brimonidine Ophthalmic Solution | Drug: Aceclidine+Brimonidine combination ophthalmic solution<br>* Combination ophthalmic solution of Aceclidine and Brimonidine<br>* Other names: LNZ101;|
| Placebo Comparator: Placebo (Vehicle) ophthalmic solution dosed bilaterally<br>Placebo: Proprietary Vehicle Ophthalmic Solution | Drug: Placebo<br>* Placebo: Proprietary Vehicle Solution<br>* Other names: Vehicle;|
| Experimental: Aceclidine ophthalmic solution dosed bilaterally<br>LNZ 100: Aceclidine ophthalmic solution | Drug: Aceclidine Ophthalmic Solution<br>* Aceclidine<br>* Other names: LNZ100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | Percentage of subjects who experience adverse events and monocular BCDVA changes at 4m. | 7 visits over a total duration of approximately 28 weeks | 

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