Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel, in Normal Healthy Volunteers
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])
Valeant Site 01
Phoenix, Arizona, United States
Valeant Site 03
Oceanside, California, United States
Valeant Site 05
Miami, Florida, United States
Valeant Site 04
Quincy, Massachusetts, United States
Blood samples will be collected for the determination of loteprednol etabonate concentrations in plasma samples
Time frame: 2 weeks
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Valeant Site 06
Kansas City, Missouri, United States
Valeant Site 02
St Louis, Missouri, United States