Lanier 2001.
Methods | Parallel‐group RCT | |
Participants | 94 participants with seasonal allergic conjunctivitis | |
Interventions | Two treatment arms: olopatadine and oral loratadine; oral loratadine. Duration of treatment 1 week | |
Outcomes | Participants' and physicians' assessment of ocular signs and symptoms Mean scores for ocular itching and redness using diaries and a 4‐point scale Time points: at baseline, day 3 and 7 after treatment |
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Country | United States | |
Number randomised, gender (male:female) | 94 participants randomised, 72 participants analysed. M:F 33:61 | |
Age mean (SD), median, range | Mean (range): olopatadine and oral loratadine 39 years (7‐74); oral loratadine 37 years (9‐74) | |
Notes | Study conducted from May to November 1998. Source of funding Alcon Pharmaceutical. Declaration of interest by the authors was not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method used to generate the allocation sequence was not described |
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 | Exclusion of 22 participants after randomisation (p.644 ‐ results): "Ten patients were not evaluable for efficacy because they did not meet inclusion/exclusion criteria or had no follow up examination... Twelve patients exited the study prematurely..." |
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 | High risk | (p.643 ‐ study design): "Because there were no control eye drops, patients were aware of their treatment groups, but clinicians performing the evaluations in the clinic were not." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | (p.643 ‐ study design): "Because there were no control eye drops, patients were aware of their treatment groups, but clinicians performing the evaluations in the clinic were not." |