Table 3.

Non-Invasive Tear Break-Up Time (First Break-Up Time) at Baseline and Post-Treatment Follow-Up Visits

Visits		OD	OS	Total
Baseline	n	119	119	238
	Mean±SD	5.2±1.97	5.6±1.96	5.4±1.97
Post-treatment	n	119	119	238
	Mean±SD	6.1±3.00	6.7±3.48	6.4±3.26
	Change from baseline (mean±SD; 95% CI)	0.9±2.85; 0.4 to 1.4	1.1±3.39; 0.5 to 1.7	1.0±3.13; 0.6 to 1.4
	p-value	0.0006	0.0004	<0.0001
Week 2	n	117	118	235
	Mean±SD	6.2±3.12	7.2±4.23	6.7±3.74
	Change from baseline (mean±SD; 95% CI)	1.1±3.29; 0.5 to 1.6	1.6±4.16; 0.9 to 2.4	1.3±3.75; 0.9 to 1.8
	p-value	0.0003	<0.0001	<0.0001
Month 1	n	118	119	237
	Mean±SD	6.2±2.71	7.3±3.87	6.8±3.38
	Change from baseline (mean±SD; 95% CI)	1.1±2.87; 0.6 to 1.5	1.7±4.06; 1.0 to 2.4	1.4±3.52; 1.0 to 1.8
	p-value	<0.0001	<0.0001	<0.0001
Month 3	n	118	117	235
	Mean±SD	6.2±3.13	7.4±3.88	6.8±3.57
	Change from baseline (mean±SD; 95% CI)	1.1±3.19; 0.5 to 1.6	1.9±4.13; 1.2 to 2.6	1.5±3.70; 1.0 to 1.9
	p-value	0.0002	<0.0001	<0.0001
Month 6	n	93	93	186
	Mean±SD	7.1±4.18	7.5±3.94	7.3±4.06
	Change from baseline (mean±SD; 95% CI)	1.9±4.15; 1.1 to 2.8	1.8±4.16; 1.0 to 2.6	1.9±4.14; 1.3 to 2.5
	p-value	<0.0001	<0.0001	<0.0001
Month 9	n	98	98	196
	Mean±SD	7.3±4.62	8.5±5.01	7.9±4.84
	Change from baseline (mean±SD; 95% CI)	2.2±4.31; 1.3 to 3.1	2.9±4.85; 1.9 to 3.8	2.5±4.59; 1.9 to 3.2
	p-value	<0.0001	<0.0001	<0.0001
Month 12	n	113	113	226
	Mean±SD	7.0±3.68	7.9±4.58	7.5±4.17
	Change from baseline (mean±SD; 95% CI)	1.9±3.69; 1.2 to 2.5	2.3±4.59; 1.5 to 3.2	2.1±4.16; 1.6 to 2.6
	p-value	<0.0001	<0.0001	<0.0001

Note: NITBUT data are shown in seconds.

Abbreviations: CI, confidence interval; NITBUT, non-invasive tear break-up time; OD, right eye; OS, left eye; SD, standard deviation.