Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

Study Overview
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Brief Summary
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This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.

Detailed Description
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To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

Official Title
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A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

Conditions
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Eye Diseases, Presbyopia, Refractive Errors, Brimonidine Tartrate, Aceclidine, Ophthalmic Solutions

Intervention / Treatment
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* Drug: Aceclidine + Brimonidine
* Drug: Aceclidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each subject 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; Be presbyopic in both eyes; Exclusion Criteria: Each subject must not: Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol; Have any active systemic or ocular disorder other than refractive disorder; Have prior, current or anticipated use of any contact lenses during study participation; Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption; Have anticipated inability to stay confined on required study days;

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 Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LNZ101<br>Aceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution | Drug: Aceclidine + Brimonidine<br>* LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution<br>|
| Other: LNZ100<br>Aceclidine 1.75% (non-preserved) ophthalmic solution | Drug: Aceclidine<br>* LNZ100 (Aceclidine) non-preserved ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentrations of LNZ100 and LNZ101 | Day 1 and Day 8 | 
| Tmax | Time of maximum plasma concentrations of LNZ100 and LNZ101 | Day 1 and Day 8 | 
| AUC0-t | Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100 | Day 1 and Day 8 | 
| AUC0-inf | Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101 | Day 1 and Day 8 | 
| T1/2 | Terminal half-life of LNZ100 and LNZ101 | Day 1 and Day 8 |