| Methods |
Parallel‐group RCT |
| Participants |
222 participants (including 42 paediatric) with seasonal allergic conjunctivitis |
| Interventions |
Two treatment arms: emedastine 0.05%; levocabastine 0.05%. Duration of treatment 42 days |
| Outcomes |
Investigator assessment of ocular signs (using a scale 0‐4) at days 3, 7, 14, 30, 42 Participant assessment of ocular symptoms (using a visual analogue scale; 0 = none, 9 = severe) at days 7, 14, 30, 42 |
| Country |
Italy and United States |
| Number randomised, gender (male:female) |
202 participants randomised. M:F 107:114 |
| Age mean (SD), median, range |
Average age (range): 30 years (4‐76) |
| Notes |
Not reported when study was conducted. Source of funding not stated. Declaration of interest by the authors was not stated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The method used to generate the allocation sequence was not described |
| 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 were nearly fully reported for each intervention group, with less than 20% lost to follow‐up (Figure 1 of the trial report). A similar percentage of participants was lost to follow‐up in each arm |
| Selective reporting (reporting bias) |
Unclear 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 |
Low risk |
Double‐masked (p.49 ‐ material and methods): "In a randomized, double‐masked..." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐masked (p.49 ‐ material and methods): "In a randomized, double‐masked..." |
