Dry Eye Assessment and Management Study

Last updated: June 23, 2022
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT02128763
UPenn IRB Protocol 816490
U10EY022881
U10EY022879
  • Ages > 18
  • All Genders

Study Summary

The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Greater than or equal to 2 of the following 4 signs in the same eye at screening andbaseline visits (Same signs must be present at Screening and Baseline visits):Conjunctival staining present greater than or equal to 1 (out of possible score of 6per eye), Corneal fluorescein staining present greater than or equal to 4 (out of apossible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5minutes.
  • Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
  • Symptoms of DED for greater than or equal to 6 months.
  • Use of or desire to use artificial tears at least 2 times per day in preceding 2weeks.
  • Ability to swallow large, soft gelcaps

Exclusion

Exclusion Criteria:

  • Allergic to ingredients in supplements or placebo
  • Contact lens wear
  • Pregnant, nursing, or lactating
  • Current ocular infection, inflammation, or acute allergic conjunctivitis
  • History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery,use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation,hemophilia or bleeding tendencies
  • Currently on anticoagulation therapy
  • Eyelid abnormalities or extensive ocular scarring
  • Use of EPA/DHA supplements in excess of 1200 mg per dayi
  • Current use, insufficient washout period, or intent to change specific treatments fordry eye disease

Study Design

Total Participants: 535
Study Start date:
November 01, 2014
Estimated Completion Date:
January 31, 2020

Study Description

The study is designed to:

  • Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial.

  • Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients.

  • Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.

Connect with a study center

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Stephen Cohen, OD PC

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Milton M. Hom, OD, FAAO

    Azusa, California 91702
    United States

    Site Not Available

  • University of California, Berkeley

    Berkeley, California 94720
    United States

    Site Not Available

  • Pendleton Eye Center

    Oceanside, California 92056
    United States

    Site Not Available

  • Wolstan and Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Peter C. Donshik, MD, PC

    Bloomfield, Connecticut 06002
    United States

    Site Not Available

  • Shettle Eye Research

    Largo, Florida
    United States

    Site Not Available

  • Eye Care Centers Management, Inc.

    Morrow, Georgia 30260
    United States

    Site Not Available

  • University of Illinois Hospital & Health Sciences

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • KU Eye Center

    Prairie Village, Kansas 66208
    United States

    Site Not Available

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Clinical Eye Research of Boston

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Minnesota Eye Consultants, P.A.

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Mulqueeny Eye Centers

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Silverstein Eye Centers

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Universtity of Rochester-Flaum Eye Institute

    Rochester, New York 14642
    United States

    Site Not Available

  • South Shore Eye Care, LLP

    Wantagh, New York 11793
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Westbury, New York 11590
    United States

    Site Not Available

  • Oculus Research at Garner at Eyecarecenter

    Raleigh, North Carolina 27603
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Northeast Ohio Eye Surgeons

    Kent, Ohio 44240
    United States

    Site Not Available

  • Scheie Eye Institute, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Southern College of Optometry

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • The Eye Centers of Racine and Kenosha

    Racine, Wisconsin 53405
    United States

    Site Not Available

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