Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

Not Applicable

Completed

• Conditions: Sjogren's Disease
• Interventions: Drug: Administration of Lotemax

• Registration Number: NCT02322528
• Lead Sponsor: University of Rochester

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Results First Submitted: 2015-09-17
• Results First Submitted QC: 2015-09-17
• Last Update Submitted: 2015-09-17
• Results First Posted: 2015-10-16
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Lotemax	Administration of Lotemax	An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.

Primary Outcome Measures

Name	Time	Method
Ocular Surface Temperature of Both Eyes	baseline, 30 minutes, week 1, week 2	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.
Visual Quality	baseline, 30 minutes, week 1, week 2	Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.

Trial Locations

Locations (1)

Flaum Eye Institute at the University of Rochester; 🇺🇸 Rochester, New York, United States