Table 2.

Safety profile of lifitegrast.

Variables	Studies Included	Lifitegrast		Placebo		N	Risk Ratio	95% Cl		p
		Event	Total	Event	Total			Lower Limit	Upper Limit
Subjects with ≥1 TEAE	3	504	936	238	824	1760	2.87	2.36	3.50	<0.001
Subjects with ≥1 ocular TEAE	4	552	1229	233	1119	2348	3.10	2.58	3.72	<0.001
Instillation site irritation	4	195	1229	33	1119	2348	6.21	4.25	9.06	<0.001
Instillation site pain	1	63	293	11	295	588	7.07	3.64	13.73	<0.001
Instillation site reaction	4	149	1229	37	1119	2348	4.03	2.79	5.84	<0.001
Instillation site pruritus	1	19	293	6	295	588	3.34	1.31	8.49	0.011
Visual acuity reduced	3	55	872	43	765	1637	1.13	0.75	1.71	0.559
Eye pain	1	6	293	5	295	588	1.21	0.37	4.02	0.753
Lacrimation increased	1	7	293	1	295	588	7.20	0.88	58.86	0.066
Eye pruritus	1	5	293	2	295	588	2.54	0.49	13.22	0.267
Ocular hyperemia	1	7	293	4	295	588	1.78	0.52	6.15	0.362
Subjects with ≥1 non-ocular TEAE	3	284	936	114	824	1760	2.71	2.13	3.46	<0.001
Nervous system disorders	1	63	359	11	359	588	6.73	3.48	13.01	<0.001
Dysgeusia	3	140	936	4	824	1760	36.06	13.28	97.88	<0.001
Withdrawal due to ≥1 TEAE	4	83	1229	25	1119	2348	3.17	2.01	4.99	<0.001

N, number of participants; TEAE, treatment emerging adverse event; 95% Cl, 95% confidence interval.