TABLE 2.

Noninferiority Analysis Comparing Latanoprost Without BAK vs. Latanoprost With BAK

Time	Study Day	IOP Difference Between Treatment Groups (95% CI)	Noninferiority Criteria Met
			N1	N2	N3
8 am	7	0.37 (−0.18, 0.92)	Y	Y	Y
	28	0.75 (0.19, 1.31)	N	Y	N
	56	0.29 (−0.27, 0.85)	Y	Y	Y
	84	0.48 (−0.10, 1.06)	Y	Y	N
10 am	7	0.52 (−0.03, 1.07)	Y	Y	N
	28	0.54 (−0.03, 1.10)	Y	Y	N
	56	0.40 (−0.17, 0.97)	Y	Y	Y
	84	0.58 (0.00, 1.17)	N	Y	N
4 pm	7	0.43 (−0.12, 0.97)	Y	Y	Y
	28	0.91 (0.36, 1.47)	N	Y	N
	56	0.63 (0.05, 1.20)	N	Y	N
	84	0.77 (0.20, 1.34)	N	Y	N
No. of times noninferiority criterion met			7	12	4
Minimum time points noninferiority criteria must be met			12	12	7

Data based on the ITT population.

For latanoprost without BAK to be considered noninferior to latanoprost with BAK, all three noninferiority criteria N1−N3 must be met for the minimum required time points.

N1, 95% CI includes 0 mm Hg; N2, the upper limit of the 95% CI is less than 1.5 mm Hg; N3, the upper limit of the 95% CI is less than 1 mm Hg.

BAK, benzalkonium chloride; CI, confidence interval; IOP, intraocular pressure; ITT, intent-to-treat.