Kidd 2003.
| Methods | Parallel‐group RCT | |
| Participants | 519 participants with seasonal allergic conjunctivitis | |
| Interventions | Three treatment arms: ketotifen fumarate 0.025%; levocabastine 0.05%; placebo. Duration of treatment 4 weeks. | |
| Outcomes | Participant assessment (mean scores) of ocular itching (using a 5‐point scale; 0 = none, 4 = severe) and watering (scale 0 = none, 3 = severe) within the first 4 days of treatment Investigator assessment of signs (redness, eyelid swelling, chemosis) after treatment (using a 5‐point scale; 0 = none, 4 = severe) |
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| Country | Australia | |
| Number randomised, gender (male:female) | 519 participants randomised, 348 participants analysed. M:F 269:254 | |
| Age mean (SD), median, range | Mean (SD): ketotifen 46.3 years (17.0); levocabastine 49.5 years (17.4); placebo 47.9 years (17.4) | |
| Notes | Not reported when study was conducted. Source of funding Novartis. 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 | RANCODE software (p.1207 ‐ study design): "Eligible subjects were randomised (RANCODE version 3.6) to one of the three treatment groups..." |
| 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 | Not intention‐to‐treat analysis, no reasons reported per protocol deviations (large numbers). Number of participants randomised (519) does not match the sum of male and female (523) |
| 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 | Identical packing (p.1207 ‐ study design): "The packaging of all trial medications was identical in appearance." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Identical packing (p.1207 ‐ study design): "The packaging of all trial medications was identical in appearance." |