Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

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).

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Key information

Conditions

Sjogren's Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of Lotemax

Drug

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

Primary outcomes

Ocular Surface Temperature of Both Eyes

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

Bausch & Lomb Incorporated

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 23, 2014
Registry last updated: Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed