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. 2015 Jun 1;2015(6):CD009566. doi: 10.1002/14651858.CD009566.pub2
Article Outcome definition Time point Azelastine Placebo Number of participants randomised (n) and comment
Canonica 2003 Investigator’s assessment of change in clinical sum score (itching, redness) (range 0‐6) 7 days Investigator: day 7
Mean sum scores (SD)
1.8 (1.4)
Participants:
Mean score (itching and conjunctiva redness) 1.65 at day 14
Investigator: day 7
Mean sum scores (SD)
3.1 (1.5)
Participants:
Mean score (itching and c. redness) 3.85 at day 14
n = 139
Main variable: Time course of sum score of main eye symptoms at day 7
Secondary outcomes: symptoms day 21, 42
Giede‐Tuch 1998 Participants’ (responders) rate sum score (itching, lacrimation, redness) decreased by at least 3 score points between day 0‐3; Investigators’ composite symptom mean score (itching, lacrimation, redness) 14 days Participants’ response rate at day 3 (0.025% and 0.05%):
73% and 82%, respectively
Investigator:
Mean score of three symptoms (0.05% dose) 7 days
2.4
Participants’ response rate: 56%
Investigator:
Mean score of 3 symptoms, 7 days
3.5
n = 151
Investigators’ mean estimated from graph (no SD)
James 2003 Investigator’s composite sum symptom score (itching, tearing, conjunctival redness) (range 0‐9), participant’s composite symptom score (itching, redness, tearing) (range 0‐9) 14 days Investigator: Mean score 2.2
Participant: Mean score 1.9
Investigator: Mean score 2.9
Participant: Mean score 2.8
n = 144
Mean scores estimated from the graphs (no SD). Days 3 and 7 also available (investigator‐reported); days 1‐14 available (participant‐reported)
Lenhard 1997 Investigator’s composite sum symptom score (itching, tearing, conjunctival redness)
(range 0‐9)
(Secondary analysis)
7 and 14 days Investigator: Mean score of 3 symptoms (itching, lacrimation, and c. redness)
2.0 at day 14
Investigator: Mean score of 3 symptoms (itching, lacrimation, and c. redness)
2.1 at day 14
n = 278
Mean scores (no SD) due to high variability for itching and marked placebo response, a secondary, more objective analysis was performed
Participant‐reported itching, c. redness, lacrimation, and swollen eyelids on a 0‐3 scale
Nazarov 2003 Investigator’s composite sum symptom score (itching, conjunctival redness) on day 7 7 days Investigator: sum score 1.9
day 14 (estimated from graph)
Investigator: sum score 3.0
day 14 (estimated from graph)
n = 116
Secondary variables: outcomes measured
days 21, 42
Participant‐reported symptoms:
used to corroborate clinical assessments
Petzold 2002
(ID 3021)
Investigator’s assessment of severity score for both (itching, redness) and separated for each symptom (itching, redness) (range 0‐3) 3 and 14 days Investigator:
Mean score day 14
0.53
Investigator:
Mean score day 14
1.39
ID 3021: n = 78
ID 3062: n = 145
ID 3034: n = 240
Treatment duration of 14 days (2 studies) or 28 days (1 study)
Petzold 2002
(ID 3062)
Investigator:
Mean score day 14
0.73
Investigator:
Mean score day 14
0.76
Petzold 2002
(ID 3034)
Investigator:
Mean score day 14
0.76
Investigator:
Mean score day 14
1.10
Sabbah 1998 Investigator’s responders rate based on decrease of at least 3 points in the sum symptom score (itching, conjunctival redness, lacrimation) (range 0‐9) between day 0 to 3; participant’s composite sum symptom score (itching, conjunctival redness, lacrimation) (range 0‐9) 3 and 14 days Investigator:
Mean sum scores 1.85 (no SD) at day 14
Investigator:
Difference in the mean sum
score (itching, conjunctival redness, and lacrimation)
‐5.4 (2.3) at day 14
Investigator:
Mean sum scores 2.45 (no SD) at day 14
Investigator:
Difference in the mean sum
score (itching, conjunctival redness, and lacrimation) ‐3.4 (3.0) at day 14
n = 113
Investigators’ mean estimated from graph (no SD)
Participant‐reported data as response rate (n, %) for composite sum symptom score
(itching, conjunctival redness, and lacrimation)
at days 3 and 14