NCT02980224.

Methods	Study design: randomized, parallel‐group, controlled trial Number randomized (total and per group): 180 participants (planned)
Participants	Country: United States of America Age (mean ± SD, range): 18 to 90 years (planned) Gender: both (planned) 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; patient‐reported dry eye symptoms; 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; 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; female subjects of childbearing potential must have a negative urine pregnancy test atScreening. Women of childbearing potential (i.e., women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study. Exclusion criteria: allergy to fish oil or safflower oil (component of placebo softgels) or any component of the softgel material; Schirmer's test score < 5 mm at Screening in either eye; Tear break‐up time > 7 seconds at screening or baseline in either eye; 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 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 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 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; contact lens wear within 12 hours prior to any study visit; subjects determined to have worn contact lenses within 12 hours must be rescheduled; punctal cauterization or punctal plug placement within 60 days 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. These include but are not limited to the following medications:
Interventions	Intervention #1: dose of 2 OmegaD softgels twice daily Intervention #2 (control): placebo twice daily Length of follow‐up: 84 days Notes: none
Outcomes	Primary outcome(s): OSDI; TBUT Secondary outcome(s): not listed Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline and 84 days Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Recruitment status: completed Actual completion date: February 2017 Last update posted: September 11, 2019