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

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
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…"