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

Inclusion Criteria

• Subjects age ≥ 18 years and ≤ 90 years on the date of informed consent.
• All subjects must provide signed written consent prior to participation in any study-related procedures.
• At least moderate ocular surface disease as measured by an OSDI score ≥ 20 at Screening.
• Clinical diagnosis of dry eye disease supported by global clinical assessment.
• Presence of tear osmolarity in at least one eye ≥ 312 mOsm/L at both Screening and Baseline.
• Schirmer's test score (anesthetized) ≥ 5 mm in both eyes at Screening.
• TBUT ≤ 7 seconds in both eyes at Screening.
• Presence of meibomian gland dysfunction as defined by a grade of 1 or 2 on the meibomian orifice size scale in at least one eye at both Screening and Baseline. The qualifying osmolarity level and meibomian orifice size grade must be present in the same eye at both Screening and Baseline if only one eye qualifies.

Exclusion Criteria

• Any previous reconstructive or cosmetic eyelid surgery that may, in the Investigator's opinion, affect the normal function of the lids (eg, blepharoplasty, ptosis repair, entropion/ectropion repair) that could affect study parameters/assessments.
• Cataract extraction, with or without minimally invasive glaucoma surgery (eg, iStent), within 90 days prior to Screening.
• Any previous invasive glaucoma surgery (eg, trabeculectomy, shunts, valves) and/or corneal surgery (eg, penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty [DSEK]).
• 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 and throughout the study period.
• Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted with certain restrictions [see exclusion criterion 16]).
• Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia, rheumatoid arthritis, etc.) during the study period. Short-term, as-needed dosing of a systemic narcotic for ≤ 72 hours is allowed, but not at Screening or on the day of the study visit.
• Allergy to fish oil or mineral oil (component of placebo softgels) or any component of the softgel material.
• 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.
• Active or anticipated seasonal and/or perennial allergic conjunctivitis or rhinitis.
• 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 or inflammation of the eye and ocular surface scarring.
• History or presence of abnormal nasolacrimal drainage.
• Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) performed within one year prior to Screening and throughout the study period.
• Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any OTC artificial tear (preserved or unpreserved) should be continued at the same frequency and with no change in drop brand.
• Contact lens wear within 12 hours prior to Screening or any study visit; subjects determined to have worn contact lenses within 12 hours must be rescheduled.
• History of cauterization of the punctum or existing silicone punctal plug(s); history of silicone plug removal or collagen plug insertion or removal within 12 months prior to Screening and throughout the study period.
• Started or changed the dose of systemic medications known to affect tear production within 30 days prior to Screening and throughout the study period. Short-term, as-needed dosing of a sy