Table 6.

Diary card worst symptom (the symptom for each patient with the highest mean severity score during the run-in period)

Period	Statistical measurement(s)	Time point
		Morning		Afternoon		Evening		Daily average
		TOP1630 (N=31)	Placebo (N=30)	TOP1630 (N=31)	Placebo (N=30)	TOP1630 (N=31)	Placebo (N=30)	TOP1630 (N=31)	Placebo (N=30)
Baseline	n	31	30	31	30	31	30	31	30
	Mean (SD)	2.79 (1.00)	3.08 (0.79)	2.69 (0.90)	2.69 (0.74)	2.73 (0.82)	2.72 (0.76)	2.75 (0.86)	2.85 (0.67)
	Mean Δa	−0.29	–	0.00	–	0.01	–	−0.10	–
Day 15 to day 29	n	30	30	30	30	30	30	30	30
	Mean (SD)	2.39 (0.99)	2.90 (0.74)	2.23 (0.87)	2.56 (0.68)	2.36 (0.77)	2.56 (0.70)	2.33 (0.83)	2.69 (0.65)
	Mean Δa	−0.51	–	−0.33	–	−0.20	–	−0.36	–
	P-value (two-sample t-test)	0.0270**	–	0.1092	–	0.2826	–	0.0707*	–
	P-value (Wilcoxon rank sum test)	0.0546*	–	0.1205	–	0.3292	–	0.0986*	–
	Mean (SD) change from baseline	−0.40 (0.82)	−0.18 (0.50)	−0.46 (0.70)	−0.13 (0.55)	−0.37 (0.74)	−0.16 (0.58)	−0.42 (0.71)	−0.16 (0.46)
	Mean Δa	−0.22	–	−0.30	–	−0.21	–	−0.26	–
	P-value (two-sample t-test)	0.2941	–	0.0644*	–	0.3071	–	0.1480	–
	P-value (ANCOVA model)	0.0825*	–	0.0360**	–	0.2160	–	0.0628*	–

Notes: N in the headers represents the total number of subjects in each respective treatment group within the mITT population. Symptom score was assessed on a 0–5 scale; 0.5 increments were not allowed. Lower score indicates less symptomatology. Baseline was defined as the average of all days during the run-in period. Daily scores were obtained by averaging the morning, afternoon, and evening scores for that day. The symptom with the highest daily average score during the run-in period was selected as the worst dry eye symptom for the subject.

^aTOP1630 value minus placebo value.

^*P<0.1;

^**P<0.05.

Abbreviations: ANCOVA, analysis of covariance; ∆, difference; mITT, modified intent-to-treat.