Table 4.

Summary of TEAEs in the selected age subgroups occurring at an incidence of ≥1% by treatment

AEs (MedDRA PT), n (%)	Olopatadine 0.77% (n=330)		Vehicle (n=169)
	2–17 years (n=51)	≥18 years (n=279)	2–17 years (n=24)	≥18 years (n=145)
Ocular AEs
Vision blurred	0	16 (5.7)	0	7 (4.8)
Dry eye	0	11 (3.9)	0	5 (3.4)
Abnormal sensation in the eye	2 (3.9)	5 (1.8)	0	7 (4.8)
Corneal staining*	1 (2.0)	7 (2.6)	0	7 (4.8)
Conjunctival staining*	2 (3.9)	4 (1.5)	1 (4.2)	0
Eye pruritus	1 (2.0)	4 (1.4)	0	2 (1.4)
Eye pain	0	3 (1.1)	0	0
Eye irritation	0	1 (0.3)	1 (4.2)	4 (2.7)
Chalazion	0	0	1 (4.2)	0
Ocular hyperemia	0	3 (1.1)	0	1 (0.7)
Conjunctival hemorrhage	0	0	0	2 (1.4)
Non-ocular AEs
Headache	1 (2.0)	4 (1.4)	0	3 (2.1)
Diarrhea	0	0	0	2 (1.4)
Nausea	1 (2.0)	0	0	1 (0.7)
Tongue discoloration	1 (2.0)	0	0	0
Vomiting	1 (2.0)	0	0	0
Dysgeusia	0	8 (2.9)	0	0
Upper respiratory tract infection	3 (5.8)	3 (1.1)	0	3 (2.1)
Nasopharyngitis	0	6 (2.2)	0	3 (2.1)
Urinary tract infection	1 (2.0)	2 (0.7)	0	1 (0.7)
Pharyngitis streptococcal	1 (2.0)	0	0	0
Gastroenteritis viral	0	0	0	2 (1.4)
Influenza	1 (2.0)	2 (0.7)	0	1 (0.7)
Pyrexia	2 (3.9)	0	1 (4.2)	0
Sinus congestion	0	2 (0.7)	1 (4.2)	0
Skin discoloration	1 (2.0)	0	0	0
Ligament sprain	0	1 (0.3)	0	2 (1.4)
Ligament injury	0	0	1 (4.2)	0

Notes:

^*All of the adverse drug reactions of corneal staining and conjunctival staining were reported by one investigator who conducted fluorescein staining at some post-dose visits. Fluorescein staining was not a protocol required procedure and was not conducted at baseline (screening visits) for any subjects. Olopatadine 0.77%, olopatadine hydrochloride solution 0.77%; vehicle, olopatadine hydrochloride solution 0.77% vehicle.

Abbreviations: AE, adverse event; MedDRA, medical dictionary for the regulatory activities; PT, preferred term; TEAE, treatment-emergent adverse event.