Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Loteprednol Etabonate

• Registration Number: NCT03098953
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-04-10
• Status Verified: 2017-05
• Primary Completion: 2017-05-12
• Study Completion: 2017-05-12
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

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

Inclusion Criteria

1. 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).
2. 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.
3. Be in general good health and free of any concomitant 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.
4. Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
5. 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.

Exclusion Criteria

1. 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.
2. Have any current disease or medical condition that requires medicinal therapy.
3. Have a history of drug or alcohol abuse in the last 6 months.
4. Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
5. 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	one drop per eye for each eye

Primary Outcome Measures

Name	Time	Method
PK analysis will be performed using standard non compartmental method	Day 15/Day 1	When possible, plasma concentrations by scheduled time point and PK parameters T1/2 (Plasma drug concentration half-life)) will be summarized using descriptive statistics by Visit

Trial Locations

Locations (1)

Valeant Site 01; 🇺🇸 Inglewood, California, United States