NCT03141931.

Trial name or title	The effects of dietary supplementation with a combination of flaxseed oil, borage oil and fish oil omega‐3 fatty acids on ocular comfort including symptoms of dry eye
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single site Number randomized (total and per group): 138 participants Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: Australia Age (mean ± SD, range): not reported Gender: both sexes eligible to participate Inclusion criteria: 1. Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent 2. Must be at least 18 years old 3. Must have symptoms of ocular discomfort as measured by the Ocular Surface Disease Index (OSDI) score > 12 at the baseline visit 4. Willing to comply with the dosage and study visit schedule as directed by the investigator 5. No contact lens wear in the last 30 days and willing to refrain from contact lens wear for the duration of the study 6. No planned changes to diet and willing to not substantially alter usual diet for the duration of the study, including typical intake of fish 7. Willingness to notify the study investigator if instructed to alter diet by health/medical practitioner 8. Willing to continue using any artificial tear supplements at the same frequency throughout the study, as used before the study 9. Must have health and ocular health findings that would not prevent the participant from safely ingesting dietary supplementation with combination omega oils Exclusion criteria: 1. Any systemic disease that would preclude participants from safely ingesting dietary supplementation with combination omega oils 2. Self‐reported allergy/sensitivity to any of the study product ingredients 3. Use of any polyunsaturated fatty acid‐containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) up to 12 weeks before the start of the study 4. Use of any of the following medications (including steroids) up to 12 weeks before the start of the study or during the course of the study: ocular medication, category S3 and above; any systemic or topical medications that will affect ocular physiology (eg, antiacne medications such as Roaccutane, corticosteroid, or immunosuppressant medications such as hydrocortisone, prednisolone, and antihistamine medications such as claritine) 5. Any systemic disease that may affect ocular health (eg, Graves' disease, autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, and systemic lupus erythematosus) 6. Epilepsy or history of migraines exacerbated by flashing, strobe‐like lights 7. Eye surgery within 6 months immediately before enrollment for this study 8. Rigid or soft contact lens wearer, including orthokeratology in the last 30 days 9. Previous corneal refractive surgery 10. Pregnant or breastfeeding Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: Lacritec: concentrated omega‐3 triglycerides ‐ fish 332 mg equiv eicosapentaenoic acid (EPA), 134 mg equiv docosahexaenoic acid (DHA), 66.8 mg flaxseed oil (linseed oil), 334 mg equiv oleic acid, 58.5 mg equiv linoleic acid, 58.5 mg equiv linolenic acid, 192 mg borago officinalis seed oil fixed (borage), 434 mg equiv gamma‐linolenic acid 95.5 mg Intervention #2 (control): placebo polyethylene glycol (500 mg), oleic acid (659 mg), and propylene glycol (115 mg) Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): OSDI, ocular comfort index, DEQ‐5; each measured at 3 months of follow‐up Secondary outcome(s): non‐invasive tear break‐up time (Oculus Keratograph 5M), tear evaporation rate (vapometer), tear meniscus height (Oculus Keratograph 5M), tear volume (phenol red thread test), and tear film lipid layer thickness (LipiView ocular surface interferometer); each measured at 3 months of follow‐up Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): baseline, 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	August 21, 2017 (currently recruiting) Estimated primary completion date: October 2018
Contact information	Jacqueline Tan‐Showyin School of Optometry and Vision Science The University of New South Wales, Australia.
Notes	Date of last participant enrollment: not reported Other notes: collaborators: Stiltec Pty Ltd. and the Australian Government