Table 3.

Drug-related ocular TEAEs prior to rescue medication

	LE gel (n = 206)	Vehicle (n = 201)
Patients with at least one related AE	5 (2.4%)	15 (7.5%)
Total drug-related AEs	5	17
Eye pain	1 (0.5%)	3 (1.5%)
Foreign body sensation	1 (0.5%)	3 (1.5%)
Dry eye	1 (0.5%)	1 (0.5%)
Eye irritation	1 (0.5%)	2 (1.0%)
Ocular hyperemia	0	2 (1.0%)
Photophobia	0	1 (0.5%)
Punctate keratitis	0	1 (0.5%)
Increased lacrimation	1 (0.5%)	0
Ocular discomfort	0	2 (1.0%)
Blurred vision	0	1 (0.5%)
IOP increased	0	1 (0.5%)

Abbreviations: LE, loteprednol etabonate; TEAE, treatment-emergent adverse event; IOP, intraocular pressure.