Table 5.

The number and percentage of eyes in the per-protocol population for which tearing was present at the indicated times for placebo-treated compared to BBOS 1.5%-treated eyes

	Time of tearing grading post-CAC	Number of eyes with tearing present		Difference in % of eyes with tearing (placebo – BBOS 1.5%)	P-value for difference
		Placebo (n=140) (%)	BBOS 1.5% (n=140) (%)
Visit 5: 15-min onset of action	7 min	55 (39)	9 (6)	33	<0.0001
	15 min	38 (27)	11 (8)	19	<0.0001
	20 min	38 (27)	13 (9)	18	0.0002
Visit 4: 8-hour persistence of action	7 min	55 (39)	13 (9)	30	<0.0001
	15 min	55 (39)	9 (6)	33	<0.0001
	20 min	38 (27)	13 (9)	18	0.0003
Visit 3B: 16-hour persistence of action	7 min	46 (33)	21 (15)	18	0.0008
	15 min	45 (32)	12 (9)	23	<0.0001
	20 min	32 (23)	12 (9)	14	0.0016

Note: P-values were derived using Fisher’s exact test and applying multiplicity corrections derived using the false discovery rate method.

Abbreviations: BBOS, bepotastine besilate ophthalmic solution; CAC, conjunctival allergen challenge; min, minute(s); n, number of eyes.