Azevedo 1991.
Methods | Parallel‐group RCT | |
Participants | 63 participants recruited with moderate or severe allergic conjunctivitis | |
Interventions | Three treatment arms: levocabastine 0.5 mg/ml eye drops; sodium cromoglycate 20 mg/ml eye drops; placebo eye drops. Duration of treatment 28 days | |
Outcomes | Participant assessment (ocular irritation, redness, photophobia, tearing, swollen eyelids, conjunctival oedema using a 4‐point scale; 0 = none, 3 = severe) Investigator assessment (ocular irritation, redness, photophobia, tearing, swollen eyelids, conjunctival oedema, using a 4‐point scale; 0 = none, 3 = severe) Time points: at baseline and day 14 and 28 of treatment |
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Country | Portugal | |
Number randomised, gender (male:female) | 63 participants randomised, 60 participants analysed. M:F 24:36 | |
Age mean (SD), median, range | Median (range): levocabastine 27 years (13‐55); sodium cromoglycate 26 years (9‐46); placebo 34 years (12‐51) | |
Notes | Not reported when study was conducted. Source of funding not reported. 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 list (p.691 ‐ treatment and methods): "Patients were randomly allocated (on the basis of a computer‐generated list) to three groups..." |
Allocation concealment (selection bias) | Unclear risk | 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 the 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.691 ‐ treatment and methods): "The trial featured a doubled‐blind, parallel groups design" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked (p.691 ‐treatment and methods): "The trial featured a doubled‐blind, parallel groups design" |