A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure

Table 4

Treatment-related adverse events reported in two or more patients in one treatment group.

Adverse event	TFC, n (%)	DFC, n (%)	value^a
	()	()
Conjunctival hyperemia	22 (23.7)	3 (3.1)	<0.001^a
Eye irritation	13 (14.0)	4 (4.1)	0.016^a
Dry eye	8 (8.6)	1 (1.0)	0.016^b
Eye pruritus	6 (6.5)	2 (2.0)	0.161^b
Somnolence	4 (4.3)	8 (8.2)	0.272^a
Allergic conjunctivitis	4 (4.3)	1 (1.0)	0.202^b
Punctate keratitis	1 (1.1)	4 (4.1)	0.369^b
Skin hyperpigmentation	3 (3.2)	0	0.114^b
Asthenia	2 (2.2)	1 (1.0)	0.613^b
Dizziness	2 (2.2)	1 (1.0)	0.613^b
Eyelid pruritus	2 (2.2)	0	0.236^b
Dry mouth	0	2 (2.0)	0.498^b

DFC: dual fixed-combination; TFC: triple fixed-combination. ^aPearson’s chi-square test. ^bFisher’s exact test.