James 2003.

Methods	Parallel‐group RCT
Participants	144 participants with seasonal allergic conjunctivitis
Interventions	Three treatment arms: azelastine; sodium cromoglycate; placebo. Duration of treatment 14 days
Outcomes	Participants' assessment of symptoms (composite score): itching, redness, tearing, foreign body sensation, photophobia, soreness, discharge (range 0‐9) using participant's diary during treatment (14 days) Investigator assessment of itching, tearing, conjunctival redness (range 0‐9, composite sum score) Time points: at day 3, 7, and 14 after treatment
Country	Germany and United Kingdom
Number randomised, gender (male:female)	144 participants randomised, 136 participants analysed. M:F 51:93
Age mean (SD), median, range	Mean (range): azelastine 37.1 years (16‐65); sodium cromoglycate 35.5 years (18‐65); placebo 35.8 years (18‐64)
Notes	Study conducted from April to September 1995. Source of funding: ASTA Medica AG (now VIATRIS GmbH & Co. KG). 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	Unclear risk	Partial double‐masked (p.314 ‐ study design): "partial double‐blind, parallel‐group... The appearance and application regimen of placebo eye drops was identical to azelastine and the study was double‐blind in this respect."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Partial double‐masked (p.314 ‐ study design): "However, the study was open in respect of sodium cromoglycate‐treated patients where the bottle size and dosage regimen identified this treatment to the investigator."