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