Giede‐Tuch 1998.
Methods | Parallel‐group RCT | |
Participants | 151 participants with seasonal allergic conjunctivitis or rhinoconjunctivitis for at least 1 year | |
Interventions | Three treatment arms: azelastine 0.025%; azelastine 0.05%; placebo. Duration of treatment 14 days | |
Outcomes | Participant‐assessed itching, tearing, and redness. Sum score (itching, tearing, redness) and rates of decreased scores by at least 3 score points between day 0‐3 using a 4‐point scale (0 = none, 3 = severe) were used Investigator‐assessed itching, tearing, and redness. A composite sum symptom mean score (itching, tearing, redness) using a 4‐point scale (0 = none, 3 = severe) was analysed Time points: at baseline, day 3, 7, and 14 after treatment |
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Country | Germany | |
Number randomised, gender (male:female) | 151 participants randomised, 129 participants analysed. M:F 66:85 | |
Age mean (SD), median, range | Mean (SD) azelastine 0.025% 35.4 years (11.4); azelastine 0.05% 35.2 years (10.7); placebo 35.9 years (11.5) | |
Notes | Study conducted from March to September 1994. Source of funding not stated. 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 | Low risk | Data were nearly fully reported, with less than 15 % lost to follow‐up, and 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.858 ‐ study design): "The investigation was performed as a double‐blind, randomized, placebo‐controlled study…" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐masked (p.858 ‐ study design): "The investigation was performed as a double‐blind, randomized, placebo‐controlled study…" |