Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

University of Rochester

Status: Completed

Conditions: Sjogren's Disease

Treatments: Drug: Administration of Lotemax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02322528

47817

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Administration of Lotemax

Other group

Description:

An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.

Treatment:

Drug: Administration of Lotemax