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

Sarker 2011.

Methods Parallel‐group RCT
Participants 92 participants with allergic conjunctivitis
Interventions Two treatment arms: ketotifen fumarate 0.025%; olopatadine hydrochloride 0.1%. Duration of treatment 2 weeks
Outcomes Assessment of ocular sign and symptoms (mean scores) for itching, tearing, hyperaemia, photophobia (using a 4‐point scale; 0 = none, 3 = severe)
Time points: at baseline and 2 weeks treatment period
Unclear if outcomes were measured by participants or clinicians, or both
Country Bangladesh
Number randomised, gender (male:female) 92 participants randomised, 83 participants analysed. M:F 36:47
Age mean (SD), median, range Mean (SD): ketotifen 28 years (12); olopatadine 28 years (11). Overall range 12‐50 years
Notes Source of funding not stated. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation list (p.547 ‐ treatment allocation and follow‐up): "Patients who were found to be eligible according to selection criteria were recruited in to one of the treatment groups according to a stratified randomisation list based on age and sex."
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 (p.547 ‐ treatment allocation and follow‐up): "Study medications were provided in identical containers so that both patients and investigators remained blinded."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Study conducted from 1 January to 31 December 2007. Double‐masked (p.547 ‐ treatment allocation and follow‐up): "Study medications were provided in identical containers so that both patients and investigators remained blinded."