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 |
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Petzold 2002 (ID 3034) |
Investigator: Mean score day 14 0.76 |
Investigator: Mean score day 14 1.10 |
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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 |