Bhargava 2016a.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (3 sites) Number randomized (total and per group): 130 participants in total; 65 participants in each treatment group Unit of randomization (individual or eye): individual Exclusions after randomization: 8 in the omega‐3 treatment group (due to gastric intolerance) Losses to follow‐up: 6 participants in the omega‐3 treatment group Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): Y (90%) Reported subgroup analysis? (Y/N): N
Participants	Baseline characteristics Country: India Age (mean ± SD, range): 47.7 ± 3.8 (range 24 to 68) years in the omega‐3 treatment group; 48.9 ± 4.5 (range 21 to 70) years in the control group Gender: 25 men and 40 women in the treatment group; 27 men and 38 women in the control group Inclusion criteria: 1. Patients with rosacea having dry eye symptoms were enrolled based on their response to (Dry Eye Scoring System, DESS) a questionnaire of common symptoms of dry eye. The minimum score for inclusion is 1 (ie, any patient having dry eye symptoms). A score of 0 to 3 was assigned to dry eye‐related symptoms Exclusion criteria: 1. Patients with corneal or episcleral/scleral involvement 2. Allergic conjunctivitis 3. Contact lens wear 4. Herpetic eye disease 5. Diabetes 6. Other skin disease 7. Inability to swallow soft gel capsules 8. Regular course of aspirin or anticoagulants (cyclo‐oxygenase‐2 inhibitors) 9. 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): olive 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 (beta‐blockers, benzodiazepines, and antihistamines) were discontinued 3 weeks before the intervention. During this period, all participants were prescribed 0.5% carboxymethylcellulose eye drops 4 times a day. However, patients were instructed to not use tear supplements at least 2 hours before tear film testing
Outcomes	Primary outcome(s): "change in" symptoms of dry eye, although data are reported as endpoint data Secondary outcome(s): meibomian gland score (MGS); Schirmer test with anesthesia; TBUT. 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, 1, 3, and 6 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: January 2013 to June 2014 Funding source(s): "we do not have any financial interest in the copyrighted Dry Eye Scoring System (DESS)" Conflicts of interest: "the authors report no conflicts of interest" 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 disk operating system‐based software"
Allocation concealment (selection bias)	Low risk	"The codes were sealed in blue‐colored envelopes that 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 about the contents. The two types of capsules and packs were similar to each other"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"The independent investigator (KS) was masked to the information obtained from the questionnaire" It is unclear whether the outcome assessor was masked to treatment assignment
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