Bhargava 2015b.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (3 sites) Number randomized (total and per group): 496 participants in total; 240 participants in the treatment group; 256 participants in the placebo group Unit of randomization (individual or eye): individual Exclusions after randomization: 8 participants, for impression cytology slides Losses to follow‐up: 14 participants dropped out of the treatment group due to gastric intolerance and non‐compliance. Unit of analysis (individual or eye): individual (1 eye selected at random) Reported power calculation? (Y/N): Y (90% power) Reported subgroup analysis? (Y/N): N
Participants	Baseline characteristics Country: India Age (mean ± SD, range): not reported Gender: 496 women in total Inclusion criteria: 1. Female contact lens users experiencing dry eye symptoms and lens wear discomfort Exclusion criteria: 1. Current ocular infection 2. History of laser in situ keratomileusis 3. Allergic conjunctivitis 4. Herpetic eye disease 5. Diabetes 6. Liver disease 7. Pregnant or lactating mothers 8. HIV 9. Hepatitis B and C 10. Inability to swallow soft gel capsules 11. Taking aspirin or anticoagulant therapy 12. Allergic to fluorescein Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1 (treatment group): oral capsule containing EPA 180 mg and DHA 120 mg, 2 capsules/time, twice daily (daily dose of 720 mg EPA and 480 mg DHA) Intervention #2 (control group): corn oil (dose not reported) Length of follow‐up: 6 months Notes: systemic (tetracyclines and corticosteroids) or topical medications (other than artificial tear supplements) that could affect tear film or meibomian gland function were discontinued before the intervention. However, patients were instructed not to use artificial tear preparations 2 hours before testing. Computer work was not allowed during the course of the study as concurrent use of visual display terminals may independently influence ocular surface changes
Outcomes	Primary outcome(s): "decrease from baseline" in symptoms of dry eye and contact lens wear discomfort, but reported as endpoint data Secondary outcome(s): Schirmer test; TBUT; Nelson grade (for cellular morphology and goblet cell density). Although these outcomes were described to be measured as "change from baseline," the manuscript reports endpoint data Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, 3 and 6 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: not reported Funding source(s): "the authors have no funding or conflicts of interest to disclose" Conflicts of interest: "the authors have no funding or conflicts of interest to disclose" Publication language: English Registered on clinical trials registry? (Y/N): N
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The allocation codes were generated by a DOS‐based software"
Allocation concealment (selection bias)	Low risk	"The codes were sealed in blue envelopes and were opened by health care personnel not involved in patient care"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The subjects were masked to the contents. The 2 types of capsules and packs were similar to each other"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"The independent investigator (K.S.) was masked to the information obtained from the questionnaire" "A single examiner performed CIC and was masked to information obtained from the questionnaire" It is unclear whether outcome assessor was masked to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	"All dropouts were included for analysis based on the last‐observation‐carried‐forward method"
Selective reporting (reporting bias)	Unclear risk	No access to study protocol or clinical trials registry
Other bias	Low risk	No other apparent sources of bias