TABLE 3.

Summary of Adverse Events, including all Ocular Adverse Events and Nonocular Adverse Events Occurring in ≥5% of Patients in Any Treatment Group

	Vehicle, no. (%), (n = 43)	OC-01, 0.006 mg, no. (%), (n = 47)	OC-01, 0.03 mg, no. (%), (n = 48)	OC-01, 0.06 mg, no. (%), (n = 44)
Patients with at least 1 TEAE	11 (26)	33 (70)	44 (92)	41 (93)
Patients with at least 1 SAE	0	0	1 (2)	0
Patients with at least 1 treatment-related SAE	0	0	0	0
Patients with TEAEs leading to withdrawal	0	0	1 (2)	3 (7)
Patients with fatal TEAEs	0	0	0	0
Patients with at least 1 ocular TEAE	7 (16)	1 (2)	2 (4)	1 (2)
Summary of ocular TEAEs occurring in at least 5% of patients
Visual acuity reduced	3 (7)	1 (2)	1 (2)	0
Patients with at least 1 nonocular TEAE	5 (12)	33 (70)	44 (92)	41 (93)
Summary of nonocular TEAEs occurring in at least 5% of patients
Sneezing	0	29 (62)	38 (79)	37 (84)
Cough	0	4 (9)	6 (13)	11 (25)
Instillation site irritation	0	3 (6)	8 (17)	8 (18)
Throat irritation	0	0	7 (15)	9 (20)
Dysesthesia pharynx	0	5 (11)	4 (8)	3 (7)
Nasal dryness	2 (5)	1 (2)	0	0
Headache	1 (2)	0	0	2 (5)