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Completed

NCT Number: NCT03098953

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

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Valeant Site 01

Inglewood, California, 90301, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.
  • 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.

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.

Treatment and study plan

Loteprednol Etabonate

Drug

one drop per eye for each eye

Other names: LE gel

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of LE Ophthalmic Gel

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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