Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

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.

Key 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 concomititant 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.
• Have a normal physical examination and clinical laboratory evaluation

Key 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.