Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

Inclusion Criteria:

1. Subjects age ≥ 18 years and ≤ 90 years on the date of informed consent.

2. All subjects must provide signed written consent prior to participation in anystudy-related procedures.

3. At least moderate ocular surface disease as measured by an OSDI score ≥ 20 atScreening.

4. Clinical diagnosis of dry eye disease supported by global clinical assessment.

5. Presence of tear osmolarity in at least one eye ≥ 312 mOsm/L at both Screening andBaseline.

6. Schirmer's test score (anesthetized) ≥ 5 mm in both eyes at Screening.

7. TBUT ≤ 7 seconds in both eyes at Screening.

8. Presence of meibomian gland dysfunction as defined by a grade of 1 or 2 on themeibomian orifice size scale in at least one eye at both Screening and Baseline. Thequalifying osmolarity level and meibomian orifice size grade must be present in thesame eye at both Screening and Baseline if only one eye qualifies.

Exclusion Criteria:

1. Any previous reconstructive or cosmetic eyelid surgery that may, in theInvestigator's opinion, affect the normal function of the lids (eg, blepharoplasty,ptosis repair, entropion/ectropion repair) that could affect studyparameters/assessments.

2. Cataract extraction, with or without minimally invasive glaucoma surgery (eg,iStent), within 90 days prior to Screening.

3. Any previous invasive glaucoma surgery (eg, trabeculectomy, shunts, valves) and/orcorneal surgery (eg, penetrating keratoplasty, lamellar keratoplasty, Descemet'sstripping endothelial keratoplasty [DSEK]).

4. Lid scrubs with over-the-counter (OTC) products (eg, OCuSOFT lid scrub, SteriLid,baby shampoo, etc.) and/or warm compresses within 14 days prior to Screening andthroughout the study period.

5. Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21days prior to Screening and throughout the study period (systemic mast cellstabilizers are allowed, and systemic antihistamines are permitted with certainrestrictions [see exclusion criterion 16]).

6. Chronic daily use (defined as > 7 consecutive days at the recommended dosingfrequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia,rheumatoid arthritis, etc.) during the study period. Short-term, as-needed dosing ofa systemic narcotic for ≤ 72 hours is allowed, but not at Screening or on the day ofthe study visit.

7. Allergy to fish oil or mineral oil (component of placebo softgels) or any componentof the softgel material.

8. Clinically significant eyelid deformity or eyelid movement disorder that is causedby conditions such as notch deformity, incomplete lid closure, entropion, ectropion,hordeolum, or chalazion.

9. Active or anticipated seasonal and/or perennial allergic conjunctivitis or rhinitis.

10. Previous ocular disease leaving sequelae or requiring current topical eye therapyother than for dry eye disease, including, but not limited to, active corneal orconjunctival infection or inflammation of the eye and ocular surface scarring.

11. History or presence of abnormal nasolacrimal drainage.

12. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK)performed within one year prior to Screening and throughout the study period.

13. Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any OTCartificial tear (preserved or unpreserved) should be continued at the same frequencyand with no change in drop brand.

14. Contact lens wear within 12 hours prior to Screening or any study visit; subjectsdetermined to have worn contact lenses within 12 hours must be rescheduled.

15. History of cauterization of the punctum or existing silicone punctal plug(s);history of silicone plug removal or collagen plug insertion or removal within 12months prior to Screening and throughout the study period.

16. Started or changed the dose of systemic medications known to affect tear productionwithin 30 days prior to Screening and throughout the study period. Short-term,as-needed dosing of a systemic medication is allowed with certain restrictions. One 7-day course of systemic antihistamines is allowed, but not within 7 days ofScreening or any other study visit. One short (≤ 72 hour) course of the othersystemic medications that affect tear production is allowed but not within 30 daysof Screening or on the day of any other study visit. These include, but are notlimited to, the following medications:

• Immunomodulators

• Tricyclic antidepressants

• Diuretics

• Corticosteroids (intranasal, inhaled, topical dermatological, and perianalsteroids are permitted)

17. Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidalanti-inflammatory drugs [NSAIDs], anti-glaucoma medications, anti-microbials),topical macrolides, or oral nutraceuticals (fish, flax, black currant seed oils,etc.) within 21 days prior to Screening and throughout the study period.

18. Use of oral tetracyclines or oral macrolides within 21 days prior to Screening andthroughout the study period; use of isotretinoin (Accutane®) within 90 days prior toScreening and throughout the study period.

19. Chronic daily use (defined as > 7 consecutive days at the recommended dosingfrequency) of oral NSAIDs during the study period. ANY use of oral NSAIDs during thestudy period must be discussed with the Medical Monitor. Aspirin of any dosage ispermitted.

20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, ornot using a medically acceptable form of birth control. Acceptable methods includethe use of at least one of the following: intrauterine device (IUD), hormonal (oral,injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), orabstinence. An adult woman is considered to be of childbearing potential unless sheis 1 year postmenopausal or postsurgical hysterectomy. All women of childbearingpotential, including those post-tubal ligation, must have a negative urine pregnancytest result at Visit 1 (Screening), Visit 2 (Baseline), and Visit 4 (Day 84)examinations and must intend to not become pregnant during the study.

21. Participation in any drug or device clinical investigation within 30 days prior toentry into this study and/or during the period of study participation.