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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT03098953

Run by

Bausch & Lomb Incorporated

People needed

15

Starts

2017-04-10

Expected to finish

2017-05-12

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Valeant Site 01 — Inglewood, California, United States

Full record on ClinicalTrials.gov

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