Table 4.

Most frequent adverse events by treatment group (≥1%)

Adverse event	AzaSite Plus™ (N=140)	AzaSite® (N=141)	Dexamethasone (N=136)
Eye disorders
Eye disorder	3 (2.1%)	0	6 (4.4%)
Visual acuity reduced	2 (1.4%)	2 (1.4%)	2 (1.5%)
Punctate keratitis	3 (2.1%)	0	2 (1.5%)
Vision blurred	2 (1.4%)	0	2 (1.5%)
Conjunctiva edema	0	2 (1.4%)	0
Eye discharge	0	2 (1.4%)	0
Eyelid edema	2 (1.4%)	0	0
Gastrointestinal disorders
Nausea	2 (1.4%)	1 (0.7%)	1 (0.7%)
GD&A
Instillation site irritation	13 (9.3%)	17 (12.1%)	3 (2.2%)
Instillation site reaction	5 (3.6%)	4 (2.8%)	5 (3.7%)
Instillation site pain	5 (3.6%)	2 (1.4%)	1 (0.7%)
Instillation site pruritus	3 (2.1%)	2 (1.4%)	1 (0.7%)
Infections and infestations
Nasopharyngitis	0	0	3 (2.2%)
Influenza	0	2 (1.4%)	0
Sinusitis	0	2 (1.4%)	0
Injury, poisoning, procedure
Foreign body in eye	0	0	2 (1.5%)
Nervous system disorder
Headache	2 (1.4%)	2 (1.4%)	0

Note: AzaSite® and AzaSite Plus™ manufactured by InSite Vision Incorporated, Alameda, CA, USA.

Abbreviation: GD&A, general disorders and administration site.