Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

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, in Normal Healthy Volunteers

Detailed Description
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The primary objective of this study is to evaluate the systemic pharmacokinetics (PK) of LE (loteprednol etabonate ophthalmic gel), 0.38% in normal healthy volunteer subjects at least 18 years of age and with a normal ophthalmic history. Systemic PK will be assessed in this study after a single dose and after 2 weeks of daily BID dosing.

Official Title
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Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers

Conditions
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Eye Pain

Intervention / Treatment
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* Drug: Loteprednol Etabonate Ophthalmic Gel


Participation Criteria
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Eligibility Criteria
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Key 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 concomititant 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. Have a normal physical examination and clinical laboratory evaluation Key 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol Etabonate Ophthalmic Gel<br>Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel]) | Drug: Loteprednol Etabonate Ophthalmic Gel<br>* Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])<br>* Other names: LE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples |  | 2 weeks |