Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate

Criteria

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