Efficacy and Safety of an Ophthalmic DMPC-Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial

Table 2

Phase I: treatment-related adverse events (34 AE/25 subjects).

	Control (n = 12)	PRO-176 (n = 13)
Patients with AE, n (%)	7 (58.3)	9 (69.2)
Related-AE, n (%)	14 (82.4)	9 (52.9)
Unexpected/expected related-AE, %	0/100	0/100
Unrelated-AE, n (%)	3 (17.6)	8 (47.1)
Unexpected/expected unrelated-AE, %	33.3/66.7	50/50
Causality term, n (%)
Possible	6 (35.3)	6 (35.3)
Probable or likely	9 (52.9)	7 (41.2)
Unlikely	2 (11.8)	4 (23.5)
Nonocular AE, n (%)	0 (0)	1 (5.9)
Ocular AE, n (%)	17 (100)	16 (94.1)
Burning eye, %	23.5	35.3
Itching	23.5	0
Ocular pain, %	11.8	5.9
Foreign body sensation, %	5.9	11.8
Other, %	35.3	47
Total AE, n	17	17

Notes. Data show frequency (percentage), n = 25 randomized subjects. No significant differences between groups, all values (the chi-square) were >0.05. For both groups, 100% of related-adverse events were expected. Abbreviations. AE, adverse event.