Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

NCT03063489 | Completed Phase 1 DMC

• 1 other identifier: 864
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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

Conditions

Eye Pain

Outcome Measures

Primary Outcomes (1)

• Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples

  2 weeks

Study Arms (1)

Loteprednol Etabonate Ophthalmic Gel

EXPERIMENTAL

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Drug: Loteprednol Etabonate Ophthalmic Gel

Interventions

Loteprednol Etabonate Ophthalmic Gel DRUG

Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])

Also known as: LE

Loteprednol Etabonate Ophthalmic Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (6)

Valeant Site 01

Phoenix, Arizona, 85032, United States

Location

Valeant Site 03

Oceanside, California, 92056, United States

Location

Valeant Site 05

Miami, Florida, 33143, United States

Location

Valeant Site 04

Quincy, Massachusetts, 01269, United States

Location

Valeant Site 06

Kansas City, Missouri, 64111, United States

Location

Valeant Site 02

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Denise Ramjit

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 24, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (6)