Melamed 1994.
Methods | Parallel‐group RCT | |
Participants | 86 participants with seasonal allergic conjunctivitis | |
Interventions | Two treatment arms: nedocromil sodium; placebo. Duration of treatment 8 weeks | |
Outcomes | Participants' assessment of symptoms ‐‐ sum score itching, burning, tearing, overall eye condition Clinicians' assessment of ocular signs and symptoms (using a scale 0 = none, 4 = very severe) Time points: at baseline and peak pollen period during the 8 weeks of treatment |
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Country | United States | |
Number randomised, gender (male:female) | 86 participants randomised, 85 participants analysed. M:F 49:36 | |
Age mean (SD), median, range | Mean (range) nedocromil sodium 33.1 years (13‐60); placebo 31.1 years (13‐57) | |
Notes | Not reported when study was conducted. Source of funding: support in part by 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) | 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 and identical package (p.58 ‐ study design): "The study was designed as a multicenter, randomized, double‐masked... Active and placebo drugs were packaged identically and labeled in opaque polyethylene bottles..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked and identical package (p. 58 ‐ study design): "The study was designed as a multicenter, randomized, double‐masked... Active and placebo drugs were packaged identically and labeled in opaque polyethylene bottles..." |