Bhargava 2015a.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (3 sites) Number randomized (total and per group): 478 participants in total Unit of randomization (individual or eye): individual Exclusions after randomization: 6 participants due to gastric intolerance (in the omega‐3 treatment group); and 6 participants due to faulty impression cytology slides Losses to follow‐up: 10 in total 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 |
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| Participants |
Baseline characteristics Country: India Age (mean ± SD, range): 22.8 ± 2.5 years in the treatment group; 23.7 ± 6.8 years in the control group Gender: 219 men and 237 women, in total Inclusion criteria: 1. Symptomatic computer users (using computers for > 3 hours/d for minimum 1 year) on the basis of a questionnaire of dry eye‐related symptoms (Dry Eye Scoring System, DESS) Exclusion criteria: 1. Current ocular infection 2. Past history of laser in situ keratomileusis (LASIK) 3. Allergic conjunctivitis 4. Contact lens wear 5. Herpetic eye disease 6. Diabetes 7. Liver disease 8. Pregnant or lactating mothers 9. HIV and hepatitis B or C 10. Patients with inability to swallow soft gel capsules 11. Aspirin or anticoagulant therapy 12. Allergic to fluorescein 13. Systemic (tetracyclines and corticosteroids) or topical medications (other than artificial tear supplements) that could affect tear film or meibomian gland function Equivalence of baseline characteristics? (Y/N): N (symptoms of dry eye, P = 0.028; conjunctival impression cytology, P = 0.013) |
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| 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: 3 months Notes: participants were instructed not to use artificial tear preparations, 2 hours before testing |
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| Outcomes |
Primary outcome(s): "decrease from baseline in" symptoms of dry eye Secondary outcome(s): Schirmer test with anesthesia; 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, 1, 2, and 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
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| Notes |
Study dates: not reported Funding source(s): "we do not have any financial interest" Conflicts of interest: "none" Publication language: English Registered on clinical trials registry? (Y/N): N |
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| 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 coloured 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 as well as the investigators 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 | "the subjects underwent a detailed ocular examination by an independent investigator (SK), who was not a study surgeon" "The independent investigator (SK) was masked to the information obtained from the questionnaire" Study does not explicitly state that outcome assessors were masked to assignments |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "Statistical analysis was performed on an intent to treat basis" However, we noted that 22/474 (4.6%) randomized participants 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 | Participant treatment group baselines were not equivalent for the primary outcome measure (ie, dry eye symptom score; P = 0.028) |