Dry Eye Assessment and Management Study

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