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Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098953
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date May 18, 2017
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date May 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters (AUC0-t (Area under the time-concentration curve to the last measured time point) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day 15/Day 1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters, AUC0-∞(Area under the time-concentration curve extrapolated to infinity) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters Cmax (Maximum drug plasma concentration), Cmin (Minimum drug plasma concentration) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters RAUC (Ratio (Visit 3/Visit 2) for AUC0-t) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters RCmax (Ratio (Visit 3/Visit 2) for Cmax) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters Tmax (Time at which maximum plasma concentration achieved) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day15/Day1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters Kel (Elimination rate constant) will be summarized using descriptive statistics by Visit.
  • PK analysis will be performed using standard non compartmental method [ Time Frame: Day 15/Day 1 ]
    When possible, plasma concentrations by scheduled time point and PK parameters T1/2 (Plasma drug concentration half-life)) will be summarized using descriptive statistics by Visit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
Official Title  ICMJE Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel
Brief Summary Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel
Detailed Description This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Loteprednol Etabonate
one drop per eye for each eye
Other Name: LE gel
Study Arms  ICMJE Experimental: Loteprednol Etabonate Ophthalmic Gel
one drop per eye for each eye
Intervention: Drug: Loteprednol Etabonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 12, 2017
Actual Primary Completion Date May 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Be in general good health and free of any concomitant 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.
  4. Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Have any current disease or medical condition that requires medicinal therapy.
  3. Have a history of drug or alcohol abuse in the last 6 months.
  4. Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
  5. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098953
Other Study ID Numbers  ICMJE 881
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anya Loncaric Bausch Health Americas, Inc.
PRS Account Bausch & Lomb Incorporated
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP