Table 3.

Differences in mean ocular itching scores (observed data only) for subjects in the per-protocol population instilling BBOS 1.5% or placebo eye drops in each eye following a CAC

	Time of itching grading post-CAC	Placebo mean score (n)	BBOS 1.5% mean score (n)	Difference in mean itching score (placebo – BBOS 1.5%)*
Visit 5: 15-min onset of action	3 min	1.9 (70)	0.4 (70)	1.5
	5 min	2.1 (70)	0.5 (70)	1.6
	7 min	1.9 (70)	0.5 (70)	1.4
Visit 4: 8-hour persistence of action	3 min	2.1 (67)	0.8 (64)	1.4
	5 min	2.3 (67)	0.8 (64)	1.5
	7 min	2.1 (67)	0.8 (64)	1.3
Visit 3B: 16-hour persistence of action	3 min	2.0 (70)	1.2 (68)	0.8
	5 min	2.3 (70)	1.3 (67)	1.0
	7 min	2.1 (69)	1.2 (68)	0.9

Notes: Itching was graded by subjects in each eye at the indicated times post-CAC. Instillation of BBOS 1.5% or placebo occurred at 15 min, 8 hours, or 16 hours prior to a CAC for each subject.

^*P<0.0001 by Wilcoxon rank-sum test at each time point for all study visits and for ANCOVA analyses across all time points at a study visit.

Abbreviations: ANCOVA, analysis of covariance; BBOS, bepotastine besilate ophthalmic solution; CAC, conjunctival allergen challenge; min, minute(s); n, number of subjects providing ocular itching grades at a study visit time point.