Katelaris 2002.
Methods | Parallel‐group RCT | |
Participants | 188 participants with seasonal allergic conjunctivitis | |
Interventions | Two treatment arms: olopatadine hydrochloride 0.1%; cromolyn sodium 2% (nedocromil sodium). Duration of treatment 6 weeks | |
Outcomes | Investigator's assessment of ocular signs and symptoms: mean ocular symptom scores of itching and redness and physicians' impression scale scores, per protocol data (5‐point scale; 0 = none, 4 = very frequent) Participants' assessment of itching and redness using diary (10‐point scale; 0 = none, 9 = severe) Time points: at days 1 to 14, and 30 to 42 after treatment |
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Country | 6 European countries and Australia | |
Number randomised, gender (male:female) | 188 participants randomised, 185 participants analysed. M:F 103:82 | |
Age mean (SD), median, range | Mean (SD): olopatadine 33.0 years (19.3); cromolyn sodium 36.8 years (20.9) | |
Notes | Not reported when study was conducted. Source of funding not stated. Declaration of interest by the authors was not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated (p.1563 ‐ study procedures): "A computer‐generated randomization schedule was used to assign sequencial patients to the study treatments in an equal ratio." |
Allocation concealment (selection bias) | Unclear risk | The method used to conceal the allocation sequence was not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Analysis per‐protocol participants not intention‐to‐treat analysis. Less than 10% lost to follow‐up, and reasons were given |
Selective reporting (reporting bias) | Low risk | Evidence was available of adequate 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‐masking (p.1563 ‐ study procedures): "Double‐masking was ensured through the use of identical opaque bottles and similar‐appearing contents and labeling." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double masking (p.1563 ‐ study procedures): "Double‐masking was ensured through the use of identical opaque bottles and similar‐appearing contents and labeling." |