Sabbah 1998.
Methods | Parallel‐group RCT | |
Participants | 113 participants with seasonal allergic conjunctivitis/rhinoconjunctivitis | |
Interventions | Three treatment arms: azelastine; levocabastine; placebo. Duration of treatment 14 days | |
Outcomes | Participants' (using diaries) and physicians' assessments (sum scores) based on a decrease of the average score > 3 units for three main eye symptoms (ocular itching, tearing, and redness) Time points: at baseline and day 3 and 14 of treatment |
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Country | France | |
Number randomised, gender (male:female) | 113 participants randomised, 107 participants analysed. M:F 75:38 | |
Age mean (SD), median, range | Mean (SD): azelastine 8.3 years (2.4); levocabastine 8.2 years (2.5); placebo 8.3 years (2.3) | |
Notes | Not reported when study was conducted. Source of funding Laboratoires ASTA Medica. 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 | 10% attrition, with similar numbers lost to follow‐up between arms |
Selective reporting (reporting bias) | Low risk | Primary outcome result was reported according to protocol |
Other bias | Low risk | No 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. Masking was not done with levocabastine due to labelling, but double‐masked with other interventions |
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. Masking was not done with levocabastine due to labelling, but double‐masked with other interventions |