Bhargava 2013.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (2 sites) Number randomized (total and per group): 518 eyes of 518 participants; 264 eyes of 264 participants in the treatment group; 254 eyes of 254 participants in the control group Unit of randomization (individual or eye): individual Exclusions after randomization: 6 participants, due to faulty impression cytology slides Losses to follow‐up: 12 participants Unit of analysis (individual or eye): individual (1 eye per participant was enrolled) Reported power calculation? (Y/N): Y (80% power) Reported subgroup analysis? (Y/N): Y (patients with Sjögren’s syndrome, contact lens users, video display terminals, chronic blepharitis, and acne rosacea)
Participants	Baseline characteristics Country: India Age (mean ± SD, range): 38.8 ± 4.1 years in the treatment group; 40.1± 6.8 years in the control group Gender: 254 men and 268 women total Inclusion criteria: 1. Aged more than 16 years 2. Symptoms of dry eye 3. TBUT less than 10 s 4. Presence of lid margin scaling, telangiectasia, collarette and meibomian gland plugging on slit‐lamp examination Exclusion criteria: 1. Any pre‐existing ocular disease other than dry eye syndrome 2. Current treatment with oral tetracyclines or corticosteroids 3. Past history of herpetic eye disease, liver disease, diabetes, or laser keratomileusis (LASIK) 4. Pregnant or lactating mothers 5. Cognitive or psychiatric disorder 6. Postmenopausal women 7. HIV 8. Hepatitis B and C 9. Inability to swallow soft gel capsules 10. Current treatment with aspirin or anticoagulant therapy 11. Allergy to fluorescein 12. Malignancy or chronic infection of the lacrimal gland Equivalence of baseline characteristics? (Y/N): Y (personal communication)
Interventions	Intervention #1 (treatment group): oral 500 mg capsule containing eicosapentaenoic acid (EPA) 325 mg and docosahexaenoic acid (DHA) 175 mg, twice daily Intervention #2 (control group): oral placebo capsules containing corn oil twice daily (daily dose: 1000 mg/d) Length of follow‐up: 3 months Notes: topical medications and contact lens use were discontinued before enrollment
Outcomes	Primary outcome(s): change from baseline in subjective symptoms Secondary outcome(s): change from baseline in Schirmer test and TBUT; rose bengal score (RBS) and conjunctival impression cytology (CIC) scores (for cellular changes and goblet cell density, measured using Nelson grade) at study endpoint Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, months 1, 2, and 3 Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: not reported Funding source(s): not reported Conflicts of interest: not reported 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	"Patients were randomly assigned to one of two groups by parallel assignment. The allocation codes were generated by a DOS based computer software"
Allocation concealment (selection bias)	Low risk	"The allocation was concealed in green colored envelopes that were opened by health care staff not involved in patient care" "software (Disk operating system based) generates codes (sequentially numbered and coloured) which were sealed in envelopes and were opened by a third party who were not involved in patient care" (personal communication)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Double blind" study "The two types of capsules and packs were similar to each other (omega‐3 dietary supplementation)" "The subjects were masked to the contents" Software (disk operating system based) generates codes (sequentially numbered and colored), which were sealed in envelopes and were opened by a third party who was not involved in patient care (personal communication)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"At each visit, each subject underwent a detailed ocular examination by an independent investigator (not a study ophthalmologist)" Independent investigator performed all tests (including tear film tests) and was masked to information obtained from the dry eye questionnaire (personal communication)
Incomplete outcome data (attrition bias) All outcomes	High risk	12/518 (2.3%) participants were lost to follow‐up, and 6/518 (1.2%) were excluded from the analysis due to faulty impression cytology slides; it was not reported which treatment group these individuals belonged to
Selective reporting (reporting bias)	Unclear risk	No access to study protocol or clinical trials registry
Other bias	Unclear risk	Information regarding funding source and conflict of interest was not reported