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." |