| Methods |
Parallel‐group crossed‐over RCT |
| Participants |
30 participants recruited with allergic conjunctivitis |
| Interventions |
Two treatment arms: bepotastine besilate 1.5% ophthalmic solution; olopatadine hydrochloride 0.2% |
| Outcomes |
Participants' assessment of ocular itching (using a 5‐point Likert scale; 1 = lowest relief, 5 = highest relief) at baseline and 2 other clinic visits but also using daily diary to assess morning and evening ocular itch relief during 2 weeks of treatment |
| Country |
United States |
| Number randomised, gender (male:female) |
30 participants randomised, M:F 10:20 |
| Age mean (SD), median, range |
Mean (SD) 49.8 (2.76), range 23‐75 |
| Notes |
Study conducted in September 2011. Source of funding not stated. No authors have financial or proprietary interest in any material or method mentioned in this work |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation list (p.1733 ‐ materials and methods): "The enrolled patients were assigned sequentially according to a computer‐generated randomization list..." |
| Allocation concealment (selection bias) |
Unclear risk |
The method used to conceal the allocation sequence was not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete outcome data reported, all the participants randomised were analysed |
| 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 |
Participants were not masked to treatment allocation (p.1733 ‐ material and methods): " Each treatment was provided in the packaging originally approved by the Food and Drug Administration..." |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Investigator was masked to treatment allocation (p.1733 ‐ material and methods): "...but the single investigator was masked as to which treatment the patient was currently using." |
