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

Leino 1992.

Methods Parallel‐group RCT
Participants 195 participants with seasonal allergic conjunctivitis
Interventions Three treatment arms: nedocromil sodium 2%; sodium cromoglycate 2%; placebo. Duration of treatment 4 weeks
Outcomes Overall assessment by participants and investigators using a 4‐point scale
Country Finland
Number randomised, gender (male:female) 195 participants randomised, 185 participants analysed. M:F not stated
Age mean (SD), median, range Mean: nedocromil 20.8 years; sodium cromoglycate 19.3 years; placebo 19.7 years
Notes Not reported when study was conducted. 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 conceal the allocation sequence was not described
Allocation concealment (selection bias) Low risk (p.930 ‐ material and methods): "After 1‐2 weeks the patients were issued their appropriate eye drops by randomized code number..."
Incomplete outcome data (attrition bias) 
 All outcomes High risk Withdrawal/exclusion of participants (p.931 ‐ results): "Data were returned from 195 patients, 10 of whom withdrew without taking test treatment and were excluded."
"A further 12 patients (5 nedocromil sodium, 3 sodium cromoglycate and 4 placebo) withdrew from the study without completing the 4‐week treatment period."
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 Identical drugs packaging (p.930 ‐ medication): "All test drugs were supplied in identical 10 ml plastic bottles."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Identical drugs packaging (p.930 ‐ medication): "All test drugs were supplied in identical 10 ml plastic bottles."