Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
Primary Purpose
Eye Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Loteprednol Etabonate Ophthalmic Gel
Sponsored by
About this trial
This is an interventional supportive care trial for Eye Pain
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.
Sites / Locations
- Valeant Site 01
- Valeant Site 03
- Valeant Site 05
- Valeant Site 04
- Valeant Site 06
- Valeant Site 02
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Loteprednol Etabonate Ophthalmic Gel
Arm Description
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
Outcomes
Primary Outcome Measures
Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples
Secondary Outcome Measures
Full Information
NCT ID
NCT03063489
First Posted
February 21, 2017
Last Updated
February 21, 2017
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03063489
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loteprednol Etabonate Ophthalmic Gel
Arm Type
Experimental
Arm Description
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate Ophthalmic Gel
Other Intervention Name(s)
LE
Intervention Description
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
Primary Outcome Measure Information:
Title
Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Ramjit
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Valeant Site 01
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valeant Site 03
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Valeant Site 05
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Valeant Site 04
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
01269
Country
United States
Facility Name
Valeant Site 06
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Valeant Site 02
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
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