Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

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

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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.

Conditions

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Eye Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Loteprednol Etabonate Ophthalmic Gel

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Group Type EXPERIMENTAL

Loteprednol Etabonate Ophthalmic Gel

Intervention Type DRUG

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Interventions

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Loteprednol Etabonate Ophthalmic Gel

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Intervention Type DRUG

Other Intervention Names

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LE

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 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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes