NCT03265327.

Trial name or title	Effect of an oral supplement containing omega‐3 and omega‐6 on dry eye symptoms (TURMERIC)
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single site Number randomized (total and per group): 60 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: Canada Age (mean ± SD, range): not reported Gender: both sexes eligible to participate Inclusion criteria: 1. Over 19 years of age with full legal capacity to volunteer 2. Has read and signed an informed consent letter 3. Is willing and anticipated able to comply with daily intake of liquid oil supplements (1 teaspoon per day for 3 months) 4. Is willing and able to follow instructions and maintain the appointment schedule 5. Exhibits moderate ocular dryness symptoms, defined as i. Score ≥ 23 on the Ocular Surface Disease Index (OSDI; Allergan Inc., Irvine, CA, USA) questionnaire ii. Currently using ocular lubricating drops at least once per day, at least for the past 3 months Exclusion criteria: 1. Is participating in any concurrent clinical or research study 2. Has any known active ocular disease and/or infection 3. Currently wears or has worn contact lenses in the past 3 months 4. Has sensitivity or an allergy to products that contain fish, soy, coconut oil, or olive oil 5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable 6. Is using any systemic or topical medications (including topical corticosteroids/NSAIDs or glaucoma medications) that in the opinion of the investigator may affect a study outcome variable 7. Is currently taking, or has used, any omega‐3 or omega‐6 supplements in the last 3 months 8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study 9. Is pregnant, lactating, or planning a pregnancy at the time of enrollment 10. Is aphakic 11. Has undergone refractive error surgery 12. Is an employee of the Centre for Contact Lens Research 13. Has taken part in another (pharmaceutical) research study within the last 30 days Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: oral supplement containing fish oil, evening primrose oil, and borage oil (omega‐3 and omega‐6) Intervention #2 (control): oral supplement containing coconut oil and light olive oil Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): OSDI, SANDE questionnaire, Schirmer test, objective non‐invasive tear film stability (NIKBUT), non‐invasive tear break‐up time (NITBUT); each measured at screening, 1 month, and 3 months Secondary outcome(s): change in each of bulbar hyperemia, limbal hyperemia, tear meniscus height, meiboscore (Arita's scale), visual acuity, tear osmolarity, and omega‐3 index; each measured at screening and at 3 months Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): screening, 1 month, and 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	August 16, 2017 (currently recruiting) Estimated primary completion date: April 2018
Contact information	Dr. Jill Woods Centre for Contact Lens Research Waterloo, Ontario, Canada, 2NL 3G1
Notes	Sponsor: Nature's Way Canada