Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

NCT ID: NCT02322528

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-08-31

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).

Conditions

Sjogren's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Administration of Lotemax

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

Group Type: OTHER

Administration of Lotemax

Intervention Type: DRUG

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

Interventions

Administration of Lotemax

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

James V. Aquavella, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James V Aquavella, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Flaum Eye Institute at the University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

47817

Identifier Type: -

Identifier Source: org_study_id