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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098953
• Other study ID #: 881
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2017
• Last updated: May 16, 2017
• Start date: April 10, 2017
• Est. completion date: May 12, 2017

Study information

• Verified date: May 2017
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 12, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Loteprednol Etabonate
one drop per eye for each eye

Locations

Country	Name	City	State
United States	Valeant Site 01	Inglewood	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK analysis will be performed using standard non compartmental method	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.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-8(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit.	Day 15/Day 1
Primary	PK analysis will be performed using standard non compartmental method	When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	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.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	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.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	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.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	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.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit.	Day15/Day1
Primary	PK analysis will be performed using standard non compartmental method	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	Day 15/Day 1