Dry Eye Assessment and Management Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT02128763

Run by

University of Pennsylvania

People needed

535

Starts

2014-11-01

Expected to finish

2020-01-31

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline 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 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
• 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 2 weeks.
• Ability to swallow large, soft gelcaps

You may not qualify if…

• 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 for dry eye disease

Where it is running

• Stephen Cohen, OD PC — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Milton M. Hom, OD, FAAO — Azusa, California, United States
• University of California, Berkeley — Berkeley, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Shettle Eye Research — Largo, Florida, United States
• Eye Care Centers Management, Inc. — Morrow, Georgia, United States
• University of Illinois Hospital & Health Sciences — Chicago, Illinois, United States
• Price Vision Group — Indianapolis, Indiana, United States
• KU Eye Center — Prairie Village, Kansas, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Clinical Eye Research of Boston — Winchester, Massachusetts, United States
• University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
• Minnesota Eye Consultants, P.A. — Bloomington, Minnesota, United States
• Mulqueeny Eye Centers — Creve Coeur, Missouri, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Universtity of Rochester-Flaum Eye Institute — Rochester, New York, United States
• Oculus Research at Garner at Eyecarecenter — Raleigh, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Northeast Ohio Eye Surgeons — Kent, Ohio, United States
• Scheie Eye Institute, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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