Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Phase 1

Completed

• Conditions: Eye Pain
• Interventions: Drug: Loteprednol Etabonate Ophthalmic Gel

• Registration Number: NCT03063489
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Status Verified: 2016-12
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Loteprednol Etabonate Ophthalmic Gel	Loteprednol Etabonate Ophthalmic Gel	Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Primary Outcome Measures

Name	Time	Method
Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples	2 weeks

Trial Locations

Locations (6)

Valeant Site 03; 🇺🇸 Oceanside, California, United States

Valeant Site 05; 🇺🇸 Miami, Florida, United States

Valeant Site 06; 🇺🇸 Kansas City, Missouri, United States

Valeant Site 04; 🇺🇸 Quincy, Massachusetts, United States

Valeant Site 01; 🇺🇸 Phoenix, Arizona, United States

Valeant Site 02; 🇺🇸 St. Louis, Missouri, United States