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

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
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..."