Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

September 17, 2015 updated by: James V. Aquavella, MD, University of Rochester

Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Flaum Eye Institute at the University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Administration of Lotemax
An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
Drug: Administration of Lotemax
An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 30 minutes, week 1, week 2
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.
baseline, 30 minutes, week 1, week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: James V Aquavella, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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