Clinical trial NCT03063489: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
Official title: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Pain
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-24
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: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valeant Site 01
state: Arizona
city: Oceanside
country: United States
facility: Valeant Site 03
state: California
city: Miami
country: United States
facility: Valeant Site 05
state: Florida
city: Quincy
country: United States
facility: Valeant Site 04
state: Massachusetts
city: Kansas City
country: United States
facility: Valeant Site 06
state: Missouri
city: St. Louis
country: United States
facility: Valeant Site 02
state: Missouri
Study officials:
affiliation: Valeant Pharmaceuticals
name: Denise Ramjit
role: STUDY_DIRECTOR
References: