Möller 1994.
Methods | Parallel‐group RCT | |
Participants | 149 participants with seasonal allergic conjunctivitis | |
Interventions | Two treatment arms: nedocromil sodium; placebo. Duration of treatment 4 weeks | |
Outcomes | Investigator's and participants' (or their parents') assessment of severity of symptoms. Mean score of itching, redness, soreness, grittiness, photophobia, and general eye condition (using a 5‐point scale; 0 = none, 4 = very severe) Time points: during peak pollen in the 4 weeks of treatment |
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Country | Sweden | |
Number randomised, gender (male:female) | 149 participants randomised, 146 participants analysed. M:F 92:57 | |
Age mean (SD), median, range | Mean (range): nedocromil sodium 12 years (6‐16); placebo 13 years (6‐16) | |
Notes | Not reported when study was conducted. Source of funding: Fisons Pharmaceuticals. 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 | Use of predetermined randomised code (p.885 ‐ patients and methods): "Patients were then allocated, by a predetermined randomised code... Trial supplies were coded at source, by computer‐generated numbers randomised in a balanced blocks of four". |
Allocation concealment (selection bias) | Low risk | Conceal allocation described (p.885 ‐ patients and methods): "Patients entering the trial were assigned to treatment numbers in sequence. The codes were held in individual sealed envelopes by the investigator, to be returned unopened after the trial." |
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.884 ‐ summary): "This was a multicentre, double‐blind..." (p.885 ‐ patients and methods): "active or placebo eye drops (both contained... in addition, the placebo eye drops contained 0.0005% rivoflavin as a yellow colorant to match the 2% nedocromil sodium content of the active eye drops)." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked (p.884 ‐ summary): "This was a multicentre, double‐blind..." (p.885 ‐ patients and methods): "active or placebo eye drops (both contained... in addition, the placebo eye drops contained 0.0005% rivoflavin as a yellow colorant to match the 2% nedocromil sodium content of the active eye drops)." |