Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

Exclusion Criteria

• •1. Allergy to fish oil or safflower oil (component of placebo softgels) or any component of the softgel material.
• •2. Schirmer's test score \< 5 mm at Screening in either eye.
• •3. Tear break-up time \> 7 seconds at Screening or Baseline in either eye.
• •4. Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeolum or chalazion.
• •5. Active seasonal and/or perennial allergic conjunctivitis or rhinitis.
• •6. Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for dry eye disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
• •7. History or presence of abnormal nasolacrimal drainage.
• •8. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) performed within one year prior to Screening and throughout the study period.
• •9. Ophthalmic drop use within 2 hours prior to any study visit. Any over-the-counter (OTC) artificial tear should be continued at the same frequency and with no change in drop brand.
• •10. Contact lens wear within 12 hours prior to any study visit; subjects determined to have worn contact lenses within 12 hours must be rescheduled.
• •11. Punctal cauterization or punctal plug placement within 60 days prior to Screening and throughout the study period.
• •12. Started or changed the dose of systemic medications known to affect tear production within 30 days prior to Screening and throughout the study period. These include but are not limited to the following medications:
• •* Immunomodulators
• •* Antihistamines
• •* Tricyclic antidepressants
• •* Diuretics
• •* Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids are permitted).
• •13. Use of any topical prescription ophthalmic medications (including cyclosporine \[Restasis®, steroids, nonsteroidal anti-inflammatory drugs \[NSAIDs\], anti-glaucoma medications), oral tetracyclines or topical macrolides, oral nutraceuticals \[fish, flax, black currant seed oils, etc.\] within 21 days prior to Screening and throughout the study period.
• •14. Chronic daily use (defined as \> 7 consecutive days at the recommended dosing frequency) of oral NSAIDs during the study period. ANY use of oral NSAIDS during the study period must be discussed with the Medical Monitor.
• •15. Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.