Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

Study Overview
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Brief Summary
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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.

Official Title
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Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: LE Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Subjects must have a best-corrected visual acuity of 20/20 or better in each eye. Subjects must have no active ocular disease or allergic conjunctivitis. Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes. Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen. Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) Exclusion Criteria: Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma. Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months. Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components. Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LE Gel<br>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. | Drug: LE Gel<br>* Single drop of LE Gel 0.5% administered to the study eye on visit 2<br>* Other names: Lotemax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 6 hours | 
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 9 hours | 
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 12 hours | 
| Tear Fluid Levels | Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose | 24 hours |