Efficacy and Safety of an Ophthalmic DMPC-Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial
Table 3
Phase II: change from baseline (day 1) at 8 and 29 days follow-up.
Control (n = 59)
PRO-176 (n = 54)
values [CI 95%]
OSDI, score ± SD
Study day 29
−31.5 ± 19.3
−33.1 ± 18.6
0.650 [−8.7, 5.5]
TBUT, seconds ± SD
Study day 8
2.02 ± 2.9
2.28 ± 2.9
0.630 [−0.8, 1.3]
Study day 29
3.56 ± 3.4
3.94 ± 2.8
0.518 [−0.08, 1.6]
FCS, score ± SD
Study day 8
−0.37 ± 0.98
−0.28 ± 0.79
0.573 [−0.23, 0.42]
Study day 29
−0.49 ± 1.1
−0.39 ± 1.0
0.615 [−0.30, 0.51]
LGCS, score ± SD
Study day 8
−0.32 ± 0.86
−0.11 ± 0.63
0.139 [−0.07, 0.49]
Study day 29
−0.37 ± 0.81
−0.39 ± 0.86
0.919 [−0.32, 0.29]
BCVA, decimal ± SD
Study day 8
−0.007 ± 0.14
0.013 ± 0.18
0.488 [−0.04, 0.08]
Study day 29
0.019 ± 0.13
0.022 ± 0.08
0.863 [−0.04, 0.04]
Notes. Data from PP population (n = 113). The Student's t-test, all values >0.05 between groups. Abbreviations. CI 95%, 95% confidence interval; BCVA, best corrected visual acuity; FCS, fluorescein corneal staining; LGCS, lissamine green conjunctival staining; OSDI, ocular surface disease index; PP, per-protocol; SD, standard deviation; TBUT, tear break-up time.
