TABLE 4.

Treatment-Emergent Adverse Events

Ocular and Nonocular Adverse Events	NOV03 QID, n (%)	NOV03 BID, n (%)	Saline BID + QID, n (%)
No. of TEAEs	62	60	67
No. of subjects with at least 1 TEAE	27 (23.7)	27 (24.3)	32 (28.8)
No. of treatment-emergent serious adverse events	3 (2.6)	1 (0.9)	0
No. of subjects discontinued treatment due to an adverse event	0	3 (2.7)	1 (0.9)
Ocular adverse events*
No. of TEAEs	22	21	18
No of subjects with at least 1 TEAE	13 (11.4)	5 (4.5)	13 (11.7)
Ocular adverse events* that occurred in more than 2% of subjects
Eye irritation	1 (0.9)	3 (2.7)	0
Eye pain	1 (0.9)	1 (0.9)	3 (2.7)
Vision blurred	3 (2.6)	0	1 (0.9)

^*Assessment relates to both eyes.