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

• ClinicalTrials.gov Identifier: NCT03098953
• Recruitment Status: Completed
• First Posted: April 4, 2017
• Last Update Posted: May 18, 2017
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Loteprednol Etabonate	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: May 12, 2017
• Actual Study Completion Date: May 12, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Loteprednol Etabonate Ophthalmic Gel; one drop per eye for each eye	Drug: Loteprednol Etabonate; one drop per eye for each eye; Other Name: LE gel

Outcome Measures

Primary Outcome Measures :

1. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit.
2. PK analysis will be performed using standard non compartmental method [ Time Frame: Day 15/Day 1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-∞(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit.
3. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
4. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters Cmax (Maximum drug plasma concentration), Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
5. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters RAUC (Ratio (Visit 3/Visit 2) for AUC0-t) will be summarized using descriptive statistics by Visit.
6. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters RCmax (Ratio (Visit 3/Visit 2) for Cmax) will be summarized using descriptive statistics by Visit.
7. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters Tmax (Time at which maximum plasma concentration achieved) will be summarized using descriptive statistics by Visit.
8. PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
   When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit.
9. PK analysis will be performed using standard non compartmental method [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

Valeant Site 01

Inglewood, California, United States, 90301

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Anya Loncaric; Bausch Health Americas, Inc.

More Information

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT03098953
• Other Study ID Numbers: 881
• First Posted: April 4, 2017
• Last Update Posted: May 18, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bausch & Lomb Incorporated:

Ocular Installation

Additional relevant MeSH terms:

Loteprednol Etabonate; Anti-Allergic Agents