Creuzot‐Garcher 2011.

Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (number of sites not stated) Number randomized (total and per group): 181 participants; 90 participants in the treatment group; 91 participants in the placebo group. Unit of randomization (individual or eye): individual Exclusions after randomization: 11 participants in the treatment group and 5 participants in the placebo group were excluded or were lost to follow‐up Losses to follow‐up: 11 participants in the intervention group and 5 participants in the placebo group were excluded or were lost to follow‐up Unit of analysis (individual or eye): individual Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Baseline characteristics Country: France Age (mean ± SD, range): 61.54 ± 11.87 years total; 61.28 ± 12.15 years in the treatment group; 61.79 ± 11.64 years in the control group Gender: 8 men and 82 women in the treatment group; 7 men and 84 women in the control group Inclusion criteria: 1. 18 to 90 years of age 2. Moderate dry eye, defined as evocative symptoms of dry eye resulting in a bilateral upper dry eye sensation or equal to 2 (on a scale of severity from 0 to 3, 2 and 3 corresponding to moderate to severe), a Schirmer test less than or equal to 10 mm in 5 minutes or tear film break time (TBUT) lower 10 s, lissamine green test score > 3 according to the classification of van Bjisterveld, and corneal fluorescein staining equal to 1, 2, or 3 (Oxford scale) Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1 (treatment group): oral capsule containing omega‐3 PUFAs (DHA 196 mg and EPA 14 mg), omega‐6 PUFA (GLA 41 mg or LA 63 mg), various vitamins (C, E, B6, B9, B12), and a trace element (zinc) (Nutrilarm, Laboratoires Thea), twice daily, 2 capsules per day Intervention #2 (control group): placebo capsule (composition and dose not reported), twice daily, 2 capsules per day Length of follow‐up: 6 months Notes: participants were allowed to take their usual eye treatments throughout the study period
Outcomes	Primary outcome(s): "dryness feeling" at study endpoint Secondary outcome(s): ocular symptoms (burning, stinging, sandy and/or gritty sensation, light sensitivity; reflex tearing; ocular fatigue); Schirmer test; TBUT; corneal fluorescein staining; conjunctival lissamine green staining; HLA‐DR expression, at study endpoint Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, months 1, 3, and 6 Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Study dates: not reported Funding source(s): Thea Laboratories funded this clinical study and drafted the article Conflicts of interest: the authors have no financial interest in Thea Laboratories and the product Nutrilarm Publication language: French Registered on clinical trials registry? (Y/N): N
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	This study was reported as a "double‐masked" study, but details of masking were not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	This study was reported as a "double‐masked" study, but details of masking were not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	11 (12.2%) participants in the treatment group and 5 (5.5%) participants in the placebo group were not included in the final analysis
Selective reporting (reporting bias)	Unclear risk	No access to study protocol or clinical trials registry
Other bias	High risk	Thea Laboratories funded this clinical study and drafted the article