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 |
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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." |