Table 3

Safety and tolerability parameters evaluated during the study period

Dose rhNGF eye drop (µg/mL)Baseline
(from day −15 to day −1)
Day 1Day 8±1Day 29±1
(end of treatment)
Day 56±4
(end of follow-up)
IOP: mm Hg (mean±SD)2015.9±1.915±1.6*14.1±1.6*14.4±1.9*14.2±2.7*
412.7±2.312.9±2.413.2±2.914.1±2.413.6±2.5
Frequency of AT use: number of daily administration (mean±SD)202.9±3.851.81±1.92.13±2.812.87±2.96
43.3±1.891.083±1.541.27±1.332.46±2.86
BCVA: number of letters ETDRS (mean±SD)2085.5±5.586.1±5.185.9±5.186.7±4.486.6±3.7
474.6±21.976.2±20.978±19.4*78.9±15.4*81.3±13.3*
VAS:
Foreign body sensation mm (mean±SD)
2048.0±27.829.6±26.5*22.8±25.3*16.6±24.7*17.4±25.8*
448.3±26.247.1±28.628.4±27.4*18.7±19.5*18.4±25.9*
VAS:
Burning/stinging mm (mean±SD)
2048.2±23.626.9±24.8*22.4±24.2*15.5±24.7*18.0±25.7*
446.8±28.639.4±28.633.1±28.621.2±23.4*16.9±23.6*
VAS: itching mm (mean±SD)2043.3±23.528.7±26.2*19.6±18.1*12.7±21.0*17.4±26.4*
454±26.940±30*29.9±29.9*19.1±22.4*18.8±21.9*
VAS: pain mm (mean±SD)2040.7±29.521.5±24.6*25.3±34.2*16.3±28.2*15.8±27.0*
429.5±26.227±2525.4±27.816.1±24.9*12.6±20.3*
VAS:
Sticky feeling mm (mean±SD)
2030.2±25.621.0±22.0*18.5±21.9*17.5±28.9*17.1±30.1*
438.8±26.737.4±30.921.9±27.3*16.6±26.4*16.2±23.6*
VAS:
Blurred vision mm (mean±SD)
2058.7±22.834.7±25.6*28.8±28.5*17.7±26.5*19.3±27.6*
454.5±31.847.5±31.737.3±32.5*25.7±28*26.1±27.9*
VAS: photophobia mm (mean±SD)2059.9±20.838.9±30.6*32.9±30.5*28.4±31.2*27.7±32.3*
448.1±31.653.1±32.537.3±31.729.8±34.8*25.1±26.8*
  • *P<0.05 Wilcoxon signed-rank test.

  • AT, artificial tears;BCVA, best-corrected visual acuity;IOP, intraocular pressure; VAS, Visual Analogue Scale.