Nazarov 2003.
Methods | Parallel‐group RCT | |
Participants | 116 participants with moderate to severe perennial allergic conjunctivitis | |
Interventions | Two treatment arms: azelastine 0.015 mg; placebo. Duration of treatment 6 weeks | |
Outcomes | Participants' and clinicians' assessment of ocular symptoms (sum score itching and redness, using a 4‐point scale; 0 = none, 3 = severe) Time points: at baseline and day 7, 21, and 42 of treatment |
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Country | Germany | |
Number randomised, gender (male:female) | 116 participants randomised and analysed. M:F 26:90 | |
Age mean (SD), median, range | Mean (range): azelastine 35.7 years (17‐63); placebo 31.7 years (17‐59) | |
Notes | Study conducted from 19 December 1998 to 14 April 1999. 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, with less than 10% lost to follow‐up, and 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.169 ‐ patients, materials and methods): "The investigation was conducted as a double‐blind, randomised..." Both drugs with identical packaging (p.169 ‐ treatment): "Both azelastine eye drops and the matching vehicle containing placebo were provided by ASTA Medica AG in identical packaging." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked (p.169 ‐ patients, materials and methods): "The investigation was conducted as a double‐blind, randomised..." Both drugs with identical packaging (p.169 ‐ treatment): "Both azelastine eye drops and the matching vehicle containing placebo were provided by ASTA Medica AG in identical packaging." |