Table 3.

Treatment-Emergent Adverse Events Observed in At Least 2 Patients

	CyclASol 0.05% (n = 51)	CyclASol 0.1% (n = 51)	Vehicle (n = 52)	Restasis (n = 53)
Patients with any TEAE*	18 (35.3%)	12 (23.5%)	14 (26.9%)	21 (39.6%)
Patients with at least 1 ocular TEAE	7 (13.7%)	7 (13.7%)	8 (15.4%)	11 (20.8%)
Ocular TEAEs†
Visual acuity related	2 (3.9%)	4 (7.8%)	1 (1.9%)	4 (7.5%)
Conjunctival hemorrhage	1 (2.0%)	0	0	2 (3.8%)
Eye irritation	0	0	2 (3.8%)	1 (1.9%)
Vision blurred	0	1 (2.0%)	0	2 (3.8%)
Eye pain	1 (2.0%)	0	1 (1.9%)	0
Instillation site pain	1 (2.0%)	1 (2.0%)	1 (1.9%)	2 (3.8%)
Conjunctivitis	0	1 (2.0%)	1 (1.9%)	1 (1.9%)

TEAE = treatment-emergent adverse event.

^*TEAE is defined as an adverse event occurring after the first dose of randomized study treatment.

^†Medical Dictionary for Regulatory Activities Version 18.1.