Conditions: Pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: yes

Brief summary:
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.

Detailed description:

Arms:
arm 1: A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.

Interventions: intervention 1: LE Gel
Intervention descriptions: intervention 1: Single drop of LE Gel 0.5% administered to the study eye on visit 2

Protocol document: