Clinical trial NCT03098953: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
Official title: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Ocular Installation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day 15/Day 1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day15/Day1
measure: PK analysis will be performed using standard non compartmental method
timeFrame: Day 15/Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Valeant Site 01
state: California
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Anya Loncaric
role: STUDY_DIRECTOR
References: