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. 2015 Jun 1;2015(6):CD009566. doi: 10.1002/14651858.CD009566.pub2

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
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"