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Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

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ClinicalTrials.gov Identifier: NCT03063489
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Eye Pain Drug: Loteprednol Etabonate Ophthalmic Gel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : February 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

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Arm Intervention/treatment
Experimental: Loteprednol Etabonate Ophthalmic Gel
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
Drug: Loteprednol Etabonate Ophthalmic Gel
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
Other Name: LE




Primary Outcome Measures :
  1. Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063489


Locations
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United States, Arizona
Valeant Site 01
Phoenix, Arizona, United States, 85032
United States, California
Valeant Site 03
Oceanside, California, United States, 92056
United States, Florida
Valeant Site 05
Miami, Florida, United States, 33143
United States, Massachusetts
Valeant Site 04
Quincy, Massachusetts, United States, 01269
United States, Missouri
Valeant Site 06
Kansas City, Missouri, United States, 64111
Valeant Site 02
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Denise Ramjit Valeant Pharmaceuticals
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03063489    
Other Study ID Numbers: 864
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Eye Pain
Eye Manifestations
Eye Diseases
Pain
Neurologic Manifestations
Loteprednol Etabonate
Anti-Allergic Agents