ACTRN12610000991011.

Trial name or title	Public title: dietary supplements and ocular (eye) comfort Scientific title: a randomized placebo‐controlled double‐masked study to investigate the effects of dietary supplementation with a combination of omega oils on ocular comfort including symptoms of dry eye
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 80 participants (planned) 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: not reported Inclusion criteria: 1. Willing to comply with the dosage and study visit schedule 2. Contact lens wearers and non‐contact lens wearers 3. At least 18 years old Exclusion criteria: 1. Current consumption of omega oil dietary supplements 2. Moderate or severe dry eye disease 3. Systematic disease that would preclude participants from safely ingesting dietary supplementation with omega oils 4. No S3 or above ocular medications 5. No use of any anticoagulants or blood thinning medications Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: capsules containing eicosapentaenoic acid ˜ 550 mg, docosahexaenoic acid ˜ 120 mg, and liolenic acids per 3 capsules per day Intervention #2 (control): placebo capsules containing paraffin oil, 3 capsules per day Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): subjective ocular comfort assessed using validated questionnaires (OCI, OSDI, SESOD, numerical rating scales, WHS, DEQ) Secondary outcome(s): non‐invasive TBUT; tear osmometry; phenol red thread test; lipid layer thickness and meibum composition; cell and nerve morphology using impression cytology and confocal microscopy Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): baseline, 1 and 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	March 2011
Contact information	Dr. Isabelle Jalbert School of Optometry and Vision Science The University of New South Wales UNSW Sydney NSW, Australia 2052
Notes	Date of last participant enrollment: March 6, 2012 Date clinical trial registry last updated: November 12, 2013 Recruitment status: completed Other notes: study sponsored by Blackmores Limited