Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

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

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

Study Overview

• Status: Completed
• Conditions: Eye Pain
• Intervention / Treatment: Drug: Loteprednol Etabonate Ophthalmic Gel

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Valeant Site 01
  • California
    • Oceanside, California, United States, 92056
      • Valeant Site 03
  • Florida
    • Miami, Florida, United States, 33143
      • Valeant Site 05
  • Massachusetts
    • Quincy, Massachusetts, United States, 01269
      • Valeant Site 04
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Valeant Site 06
    • St. Louis, Missouri, United States, 63131
      • Valeant Site 02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loteprednol Etabonate Ophthalmic Gel; Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])	Drug: Loteprednol Etabonate Ophthalmic Gel; Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel]); Other Names: LE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pain; Neurologic Manifestations; Eye Manifestations; Eye Pain; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes