Dry Eye Assessment and Management Study

Dry Eye Assessment and Management Study

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.

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.

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