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

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
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."