Canonica 2003.
| Methods | Parallel‐group RCT | |
| Participants | 139 participants recruited with moderate to severe perennial allergic conjunctivitis | |
| Interventions | Three treatment arms: azelastine 0.05% eye drops; placebo eye drops; levocabastine eye drops. Duration of treatment 6 weeks | |
| Outcomes | Investigator assessment (itching and redness). Change in clinical sum score (itching and redness using a scale range 0‐6) Participant assessment of ocular symptoms (daily diaries using a 4‐point scale; 0 = none, 3 = severe symptoms) Time points: at baseline and day 7, 21, and 42 of treatment |
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| Country | France, Italy, Spain, Russia, and United Kingdom | |
| Number randomised, gender (male:female) | 139 participants randomised. M:F 65:74 | |
| Age mean (SD), median, range | Mean (SD): azelastine group 34 years (13.7); placebo group 36 years (13.0); levocabastine 34 years (13.2) | |
| Notes | Study conducted from 2 December 1998 to 16 June 1999. Source of funding: University of Genoa, Italy and Clinical and Biometrical Development, VIATRIS GmbH & Co. KG. 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 | Randomisation code (p.323 ‐ drugs): "A predefined randomisation code was used to assign azelastine, placebo or levocabastine treatment to qualified patients in an unbalanced fashion (ratio 2:2:1)." |
| 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, with less than 10% lost to follow‐up, and the reasons were given |
| 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 | Low risk | Double‐masked (p.323 ‐ drugs): "Both azelastine eye drops and the matching vehicle containing placebo were provided by VIATRIS GmbH in identical packaging." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked (p.323 ‐ drugs): "Both azelastine eye drops and the matching vehicle containing placebo were provided by VIATRIS GmbH in identical packaging." |