Fujishima 2008.
| Methods | Parallel‐group RCT | |
| Participants | 32 participants recruited with seasonal and perennial allergic conjunctivitis | |
| Interventions | Two treatment arms: levocabastine; levocabastine and pemirolast potassium. Duration of treatment 1 week | |
| Outcomes | Participants used a diary to quantify ocular symptoms (itching, foreign body sensation, tearing, eye discharge, and hyperaemia) using visual analogue scale Investigators used a 4‐point scale (0 = none, 3 = severe) for quantifying ocular signs: conjunctival hyperaemia, conjunctival oedema, eyelid oedema, conjunctival papilla formation, and superficial punctate keratopathy Time points: at baseline and 1 week after treatment |
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| Country | Japan | |
| Number randomised, gender (male:female) | 32 participants randomised, 30 participants analysed. M:F 9:23 | |
| Age mean (SD), median, range | Mean (range): levocabastine 50.9 years (12‐81); levocabastine and pemirolast potassium 40.5 years (7‐73) | |
| Notes | Not reported when study was conducted. Source of funding unclear. Declaration of interest by the authors was not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sealed‐envelope technique (p.233 ‐ test agents): "The patients were randomly allocated to one of two groups by a sealed‐enveloped technique…" |
| Allocation concealment (selection bias) | Unclear risk | The method used to conceal the allocation sequence was not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data of all participants randomised was analysed and reported |
| Selective reporting (reporting bias) | Low risk | Evidence was available of proper outcome reporting |
| Other bias | Low risk | No apparent evidence of other risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study did not describe details on masking of participants on the intervention allocations |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study did not describe details on masking of personnel/investigators on the intervention allocations |