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

Bausch Health Americas, Inc.6 sites in 1 country15 target enrollmentFebruary 2015

ConditionsEye Pain

InterventionsLoteprednol Etabonate Ophthalmic Gel

DrugsLoteprednol Etabonate Ophthalmic Gel

Overview

Phase: Phase 1
Intervention: Loteprednol Etabonate Ophthalmic Gel
Conditions: Eye Pain
Sponsor: Bausch Health Americas, Inc.
Enrollment: 15
Locations: 6
Primary Endpoint: Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

July 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bausch Health Americas, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.