Oral Nutrition Impact on Tear Film

Hyperosmolarity is a major cause of cell damage over time and can result in apoptosis of
corneal and conjunctival cells. Determining if a patient has hyperosmolarity is critical
allowing us to offer therapies to correct the problem. Reducing and regulating osmolarity is
important in preventing potential long-term tissue compromise. Treatment leading to
decreasing tear osmolarity can improve the patient's quality of life by stabilizing vision
and, in many cases, simply allowing patients to return to normal activities.

Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human
inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for
disease treatment has resulted in several small studies as well as the use (and
over-the-counter availability) of EFA-containing nutritional supplements, including several
specifically for the treatment of DED. Unfortunately, the effects of Omega 3 on dry eye
disease have not been established to date. The purpose of this study is to better understand
the role of Omega 3 plays in the regulating tear osmolarity in patients with established
findings consistent with dry eye disease.

Inclusion Criteria:

- Age 18 to 79 at the time of informed consent.

- Must understand; be willing and able, and likely to fully comply with study
procedures, visit schedule, and restrictions.

- A diagnosis of dry eye disease based on a global clinical assessment by the attending
clinician, patient complaint of dry eye symptoms and osmolarity. There will be two
osmolarity tiers; the lower tier is an open label design based on an average
osmolarity between 316-326 mOsmo/L, and the other a group >=327 mOsmol/L. (Enrollment
in the two tiers can either be simultaneous, or the second tier can be included after
a responder analysis is done of tier 1).

Exclusion Criteria:

- Clinically significant eyelid deformity or eyelid movement disorder that is caused by
conditions such as notch deformity, incomplete lid closure, entropion, ectropion,
hordeola or chalazia.

- Previous ocular disease leaving sequelae or requiring current topical eye therapy
other than for DED, including, but not limited to: active corneal or conjunctival
infection of the eye and ocular surface scarring.

- Active ocular or nasal allergy.

- LASIK or PRK surgery that was performed within one year of Visit 1 or at any time
during the study.

- Ophthalmologic drop use within 2 hours of any study visits.

- Pregnancy or lactation at any time during the study by history.

- Abnormality of nasolacrimal drainage (by history).

- Punctal cauterization or current punctal plug placement or within 30 days of punctual
plug removal.

- Permissible Medications/Treatments- any commercially available OTC artificial tear.

- Prohibited Medications- Cyclosporine; any topical prescription medications (i.e.,
steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical
macrolides; oral nutraceuticals (flax, fish, black currant seed oils, etc...) within
3 weeks of baseline.

Started or changed the dose of chronic systemic medication known to affect tear production
including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids
or immunomodulators within 30 days of Visit 1.