Article | Outcome definition | Time point | Levocabastine | Placebo | Number of participants randomised (n) and comment |
Azevedo 1991 | Investigator’s assessment sum score (ocular irritation, c. redness, photophobia, tearing, swollen eyelids, and conjunctival oedema) (range 0‐3); participant‐reported same symptoms using VAS scale | 14 and 28 days | Investigators: Mean severity scores for each symptom (irritation, tearing, and photophobia) (data not reported, only change score from baseline) Participants: median area under the curve (%) 14% |
Investigators: Mean severity scores for each symptom (irritation, tearing, and photophobia) (data not reported, only change score from baseline) Participants: median area under the curve (%) 29% |
n = 63 Investigators' and participants’ global assessment of efficacy at the end of treatment |
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) 2.2 (1.2) Participants: Mean score 1.5 at day 14 (itching and conjunctival redness) |
Investigator: day 7 Mean sum scores (SD) 3.1 (1.5) Participants: Mean score 3.85 at day 14 (itching and conjunctival redness) |
n = 139 Main variable: Time course of sum score of main eye symptoms at day 7 Participants' mean score (no SD) estimated from graphs Secondary outcomes: symptoms day 21, 42 |
Davies 1993 | Area under the curve for participant‐reported symptoms (VAS score 0‐100, 0 = no symptoms, 100 = extremely severe symptoms); Investigator’s symptoms score (ocular irritation, c. redness, itching, photophobia, tearing, lid and conjunctival oedema) (range 0‐3) | 14 days | Participants: VAS ≤ 10 symptom‐free 37% (P < 0.01); VAS ≤ 50 symptom‐free 40% (P < 0.1) |
Participants: VAS≤ 10 symptom‐free 4% (P < 0.01); VAS ≤ 50 symptom‐free 13% |
n = 95 VAS percentages (estimated from graph) Investigator’s symptoms severity 0‐3 scale (0 = absent, 3 = severe) |
Graue 1994 | Investigator‐reported symptoms (absent, mild, moderate, or severe scale) Participant‐reported symptoms (VAS scale, 0 = no symptoms and 10 = worst possible symptoms) |
7 days | Symptoms improvement: 58% first 2 hours 88% day 1 Percentage at day 7 to be estimated from graphs |
Symptoms improvement: 33.5% first 2 hours 61% day 1 Percentage at day 7 to be estimated from graphs |
n = 40 Unclear whether graph is participant or investigator assessment Percentages of improved symptoms reported (no means and SD) |
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 1.25 (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 tearing) ‐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 tearing) at days 3 and 14 |