Dry Eye Assessment and Management Study (DREAM)

University of Pennsylvania

Status and phase

Completed

Phase 3

Conditions

Dry Eye

Treatments

Drug: Placebo

Drug: Omega-3 supplements

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02128763

UPenn IRB Protocol 816490

U10EY022879 (U.S. NIH Grant/Contract)

U10EY022881 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

535 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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 for dry eye disease