Clinical Trial: Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Valeant Pharmaceuticals International, Inc.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: February 21, 2017
Date Started: February 2015
Date Completion:
Last Updated: February 21, 2017
Last Verified: December 2016