Table 3.

Summary of efficacy endpoints between LCD and placebo groups

Visit	LCD (N = 30)	Placebo (N = 29)	P-value by ANOVA for LCD vs. placebo
	Mean ± SD	Mean ± SD
a. Schirmer’s test—average of both eyes
Baseline	6.62 ± 1.73	7.09 ± 2.45	0.3979
Day 14	9.90 ± 4.21	8.14 ± 2.55	0.0580
Day 28	12.23 ± 3.18	8.69 ± 2.90	< 0.0001**
Day 56	14.32 ± 2.51	7.43 ± 3.29	< 0.0001**
b. Ocular Surface Disease Index (OSDI) scores
Baseline	30.10 ± 4.88	32.54 ± 5.06	0.0642
Day 14	25.24 ± 4.74	30.68 ± 5.48	0.0001**
Day 28	19.16 ± 4.40	30.60 ± 5.91	< 0.0001**
Day 56	17.09 ± 4.85	31.00 ± 7.18	< 0.0001**
c. Tear film break-up time (TBUT)—average of both eyes
Baseline	8.18 ± 1.18	7.86 ± 1.25	0.3129
Day 14	9.97 ± 1.80	7.97 ± 1.48	< 0.0001**
Day 28	11.03 ± 1.32	7.93 ± 1.18	< 0.0001**
Day 56	12.13 ± 1.38	6.86 ± 1.51	< 0.0001**
d. Standardized patient evaluation of eye dryness (SPEED) score
Baseline	11.63 ± 1.25	12.21 ± 1.78	0.1559
Day 14	8.97 ± 1.30	11.03 ± 2.23	< 0.0001**
Day 28	7.07 ± 1.36	10.31 ± 2.16	< 0.0001**
Day 56	6.07 ± 1.86	12.41 ± 2.90	< 0.0001**
e. Corneal staining—average of both eyes
Baseline	1.14 ± 0.17	1.10 ± 0.17	0.3965
Day 56	0.79 ± 0.25	1.24 ± 0.20	< 0.0001**
f. Conjunctival staining—average of both eyes
Baseline	0.88 ± 0.22	0.86 ± 0.20	0.7775
Day 56	0.58 ± 0.32	1.03 ± 0.27	< 0.0001**
g. Tear osmolarity—average of both eyes
Baseline	327.23 ± 12.42	327.34 ± 11.06	0.9711
Day 56	320.42 ± 12.24	331.72 ± 11.20	0.0005**

N number of subjects in specified treatment, SD standard deviation. Between-group analysis with ANOVA

*P < 0.05

**P < 0.01