Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

Study Overview
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Brief Summary
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Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel

Detailed Description
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This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period

Official Title
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Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel

Conditions
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Healthy

Intervention / Treatment
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* Drug: Loteprednol Etabonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). Be a non-smoking male or female at least 18 years of age on the date the ICF is signed and with the capacity to provide voluntary informed consent. Be in general good health and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study. Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff. Are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (IP) on specified study days. Exclusion Criteria: Have a history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up. Have any current disease or medical condition that requires medicinal therapy. Have a history of drug or alcohol abuse in the last 6 months. Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine. Are known to have a prior positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus types 1 and 2.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol Etabonate Ophthalmic Gel<br>one drop per eye for each eye | Drug: Loteprednol Etabonate<br>* one drop per eye for each eye<br>* Other names: LE gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-∞(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit. | Day 15/Day 1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters Cmax (Maximum drug plasma concentration), Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters RAUC (Ratio (Visit 3/Visit 2) for AUC0-t) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters RCmax (Ratio (Visit 3/Visit 2) for Cmax) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters Tmax (Time at which maximum plasma concentration achieved) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit. | Day15/Day1 | 
| PK analysis will be performed using standard non compartmental method | When possible, plasma concentrations by scheduled time point and PK parameters T1/2 (Plasma drug concentration half-life)) will be summarized using descriptive statistics by Visit | Day 15/Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Installation