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

Table 1

Initial characteristics of each group (n = 63 subjects per group, from both phases).

Variable	Control	PRO-176	values
Male/female^1, %	36.5/63.5	25.4/74.6	0.247
Age^2, years ± SD	44.6 ± 15.4	47.8 ± 17.4	0.269
Comorbidities^1, n (%)	21 (33.3)	23 (36.5)	0.852
OSDI^2, score ± SD	50.3 ± 18.3	48.9 ± 19.2	0.691
TBUT^2, seconds ± SD	6.4 ± 2.2	5.9 ± 2.0	0.261
FCS^2, score ± SD	0.97 ± 1.1	0.98 ± 1.0	0.934
LGCS^2, score ± SD	0.84 ± 0.8	0.92 ± 0.7	0.552
BCVA^2, decimal ± SD	0.89 ± 0.2	0.88 ± 0.2	0.697

Notes. ¹Chi-square test, ²Student's t-test. All values >0.05 between groups. Abbreviations. FCS, fluorescein corneal staining; BCVA, best corrected visual acuity; LGCS, lissamine green conjunctival staining; OSDI, ocular surface disease index; SD, standard deviation; TBUT, tear break-up time.