Melamed 2000.

Methods	Parallel‐group RCT
Participants	189 participants with seasonal allergic conjunctivitis
Interventions	Two treatment arms: nedocromil sodium 2%; vehicle. Duration of treatment 8 weeks
Outcomes	Participants' assessment of various symptoms (composite score itching, burning, tearing, overall eye condition) and diary cards (using a scale 0 = none, 4 = very severe) to assess individual symptoms at treatment Clinicians' assessment of ocular signs and symptoms, and clinician and participant overall opinions of treatment effectiveness at baseline and peak pollen season Time scale: during the 8 weeks of treatment
Country	United States
Number randomised, gender (male:female)	189 participants randomised. M:F 104:85
Age mean (SD), median, range	Mean (range): nedocromil sodium 33.4 years (12‐65); vehicle 31.0 years (13‐67)
Notes	Study conducted in August 1986. Source of funding: in part by Fisons Pharmaceuticals.The authors did not have a financial interest in the drugs discussed within this manuscript
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 with similar percentage of participants lost to follow‐up in each arm, 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.236 ‐ study design): "The nine week studies used a double‐blind, placebo‐controlled..." Identical bottles (p.236 ‐ study protocol): "At the end of the baseline week, patients were randomised to receive either one drop of nedocromil sodium 2% or vehicle solution b.i.d in each eye, delivered from identical opaque bottles."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double‐masked (p.236 ‐ study design): "The nine week studies used a double‐blind, placebo‐controlled..." Identical bottles (p.236 ‐ study protocol): "At the end of the baseline week, patients were randomised to receive either one drop of nedocromil sodium 2% or vehicle solution b.i.d in each eye, delivered from identical opaque bottles."