Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).

Official Title
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Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax

Conditions
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Sjogren's Disease

Intervention / Treatment
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* Drug: Administration of Lotemax


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Age 50-70 Diagnosed with Sjogren's Disease Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits Either gender Any racial or ethnic origin EXCLUSION CRITERIA: Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s). Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection. Subjects who have had cataract surgery less than one year ago Use of soft or hard contact lenses. Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions). Inability to provide analyzable data

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Administration of Lotemax<br>An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response. | Drug: Administration of Lotemax<br>* An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Temperature of Both Eyes | Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays. | baseline, 30 minutes, week 1, week 2 | 
| Visual Quality | Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes. | baseline, 30 minutes, week 1, week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive instruments, Environment, Wavefront, Placido Disk, Ellipsometer, Thermal Imaging