Creuzot 2006.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): not reported if single‐ or multi‐center Number randomized (total and per group): 71 participants; 36 participants in the treatment group; 35 in the placebo group Unit of randomization (individual or eye): individual Exclusions after randomization: 4 participants in the treatment group and 7 participants in the placebo group were excluded or were lost to follow‐up Losses to follow‐up: 4 participants in the intervention group and 7 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 |
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| Participants |
Baseline characteristics Country: France Age (mean ± SD, range): 59.7 ± 14.7 years in the treatment group; 61.1 ± 11.1 years in the control group Gender: 2 men and 34 women in the treatment group; 1 man and 34 women in the control group Inclusion criteria: 1. Mild to moderate dry eye defined by lissamine green upper marking 4 according to van Bijsterveld and Schirmer test < 10 mm /5 min and/or TBUT< 10 s 2. Severe ocular surface disease that showed a superficial punctate keratitis strictly superior to 3 (of 5 by score of Oxford) or filamentary keratitis Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): Y |
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| 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 (oleic acid), twice daily, 2 capsules per day (dose not reported) Length of follow‐up: 6 months |
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| Outcomes | Primary and secondary outcome measures were not clearly distinguished Outcomes specified: Schirmer test; TBUT; corneal fluorescein staining; conjunctival lissamine green staining; reflex tearing; conjunctival hyperaemia; skin quality; "emotional quality" 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 |
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| Notes |
Study dates: not reported Funding source(s): not reported Conflicts of interest: 1 author was affiliated with a pharmaceutical company Publication language: French 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) | 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 | Four (11.1%) participants in the treatment group and 7 (20%) participants in the placebo group were excluded or were lost to follow‐up, and 2 participants in each 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 | 1 of the study authors was affiliated with a pharmaceutical company |