Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia

Study Overview
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Brief Summary
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Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Detailed Description
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A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Official Title
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A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Conditions
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Miosis, Presbyopia, Near Vision, Eye Diseases

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


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 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; Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) 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; Be presbyopic as determined at Visit 2 baseline 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 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 in either eye; Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1; Have clinically significant abnormal lens findings including early lens changes during dilated slit-lamp 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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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, randomized, efficacy and safety study
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Study To evaluate the safety and efficacy of LNZ101/LNZ100 compared with vehicle for the treatment of Presbyopia. | Percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye. compared with vehicle for the treatment of Presbyopia. | 3 hours post-treatment in the study eye at Visit 2 | 

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