Bhargava 2016b.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (3 sites) Number randomized (total and per group): 522 participants in total; 256 participants in the omega‐3 treatment group; 266 participants in the placebo group Unit of randomization (individual or eye): individual Exclusions after randomization: 26 in total; 22 (irregularly taking supplements because of bad taste and gastric intolerance) and 4 (inability to continue the trial) Losses to follow‐up: not reported 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): 28.9 ± 4.2 years in the omega‐3 treatment group; 29.6 ± 5.5 years in the control group Gender: not reported Inclusion criteria: 1. Symptomatic visual display terminal (VDT) users experiencing dry eye symptoms based on their response to the Dry Eye Scoring System questionnaire Exclusion criteria: 1. Allergic conjunctivitis 2. History of laser in situ keratomileusis 3. Contact lens wear 4. Other causes of dry eye in the office‐going population, software professionals, or university students 5. Inability to swallow soft gel capsules 6. On a regular course of aspirin or anticoagulants (cyclo‐oxygenase‐2 inhibitors) 7. 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, 4 capsules/time, twice daily (daily dose of 1440 mg EPA and 960 mg DHA) Intervention #2 (control group): olive oil (dose not reported) Length of follow‐up: 45 days 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 commenced. Moreover, patients were instructed not to use artificial tear preparations 2 hours before testing |
|
| Outcomes |
Primary outcome(s): "improvement in" symptoms of dry eye, but reported as endpoint data Secondary outcome(s): "improvement in" Schirmer test with anesthesia, TBUT, and Nelson grade on conjunctival impression cytology, but reported as endpoint data in the manuscript Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, 30 and 45 days 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 disk operating system–based software" |
| Allocation concealment (selection bias) | Low risk | "The codes were sealed in green envelopes and were opened by a health care personnel not involved in patient care" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double masked" "The subjects were masked to the contents. The two types of capsules and packs were similar to each other" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "A detailed ocular examination was performed by an independent investigator (who was not a study surgeon, K.S.)" "The independent investigator (K.S.) was masked to the information obtained from the questionnaire" It is unclear whether the outcome assessor was masked to the treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "All dropouts (n=26) 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 |