Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

Sjogren's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322528
• Other study ID #: 47817
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: September 17, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sjogren's Disease
• Sjogren's Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Flaum Eye Institute at the University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No