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. 2015 Jun 1;2015(6):CD009566. doi: 10.1002/14651858.CD009566.pub2

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
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