Höffling‐Lima 2001.
Methods | Parallel‐group RCT | |
Participants | 40 participants with allergic conjunctivitis | |
Interventions | Two treatment arms: ketotifen 0.05%; olopatadine 0.1%. Duration of treatment 30 days | |
Outcomes | Participants' assessment of severity of ocular symptoms: itching, burning, watering, discharge, photophobia (4‐point scale; 0 = none, 3 = severe) Investigator assessment of ocular signs Time points: at days 1, 2, 7, 14, and 30 after treatment |
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Country | Brazil | |
Number randomised, gender (male:female) | 40 participants randomised, 34 participants analysed. M:F 15:19 | |
Age mean (SD), median, range | Mean (range) 27 years (5‐73) | |
Notes | Study conducted from 1 February to 30 June 1999. Source of funding not stated. The authors declared no commercial interest in the drugs evaluated and did not receive any direct or indirect benefit or financial support for this study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation (p.416 ‐ methods): "A masked and randomised clinical study was conducted..." "the introduction of treatment was randomized beforehand..." |
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 15% 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 | Masking of participants (p.416 ‐ methods): "A masked and randomised clinical study was conducted..." "... and bottles with topical medications were masked by ophthalmos laboratory." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Masking of investigator (p.417 ‐ methods): "only the medical monitors delivered the drugs to patients..." |