Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Eye Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063489
• Other study ID #: 864
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2017
• Last updated: February 21, 2017
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: Valeant Pharmaceuticals International, Inc.
• 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, in Normal Healthy Volunteers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Pain

Intervention

Drug:
• Loteprednol Etabonate Ophthalmic Gel
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])

Locations

Country	Name	City	State
United States	Valeant Site 06	Kansas City	Missouri
United States	Valeant Site 05	Miami	Florida
United States	Valeant Site 03	Oceanside	California
United States	Valeant Site 01	Phoenix	Arizona
United States	Valeant Site 04	Quincy	Massachusetts
United States	Valeant Site 02	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples		2 weeks