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 1 | Day 8±1 | Day 29±1 (end of treatment) |
Day 56±4 (end of follow-up) |
|
| IOP: mm Hg (mean±SD) | 20 | 15.9±1.9 | 15±1.6* | 14.1±1.6* | 14.4±1.9* | 14.2±2.7* |
| 4 | 12.7±2.3 | 12.9±2.4 | 13.2±2.9 | 14.1±2.4 | 13.6±2.5 | |
| Frequency of AT use: number of daily administration (mean±SD) | 20 | 2.9±3.85 | – | 1.81±1.9 | 2.13±2.81 | 2.87±2.96 |
| 4 | 3.3±1.89 | – | 1.083±1.54 | 1.27±1.33 | 2.46±2.86 | |
| BCVA: number of letters ETDRS (mean±SD) | 20 | 85.5±5.5 | 86.1±5.1 | 85.9±5.1 | 86.7±4.4 | 86.6±3.7 |
| 4 | 74.6±21.9 | 76.2±20.9 | 78±19.4* | 78.9±15.4* | 81.3±13.3* | |
|
VAS:
Foreign body sensation mm (mean±SD) |
20 | 48.0±27.8 | 29.6±26.5* | 22.8±25.3* | 16.6±24.7* | 17.4±25.8* |
| 4 | 48.3±26.2 | 47.1±28.6 | 28.4±27.4* | 18.7±19.5* | 18.4±25.9* | |
|
VAS:
Burning/stinging mm (mean±SD) |
20 | 48.2±23.6 | 26.9±24.8* | 22.4±24.2* | 15.5±24.7* | 18.0±25.7* |
| 4 | 46.8±28.6 | 39.4±28.6 | 33.1±28.6 | 21.2±23.4* | 16.9±23.6* | |
| VAS: itching mm (mean±SD) | 20 | 43.3±23.5 | 28.7±26.2* | 19.6±18.1* | 12.7±21.0* | 17.4±26.4* |
| 4 | 54±26.9 | 40±30* | 29.9±29.9* | 19.1±22.4* | 18.8±21.9* | |
| VAS: pain mm (mean±SD) | 20 | 40.7±29.5 | 21.5±24.6* | 25.3±34.2* | 16.3±28.2* | 15.8±27.0* |
| 4 | 29.5±26.2 | 27±25 | 25.4±27.8 | 16.1±24.9* | 12.6±20.3* | |
|
VAS:
Sticky feeling mm (mean±SD) |
20 | 30.2±25.6 | 21.0±22.0* | 18.5±21.9* | 17.5±28.9* | 17.1±30.1* |
| 4 | 38.8±26.7 | 37.4±30.9 | 21.9±27.3* | 16.6±26.4* | 16.2±23.6* | |
|
VAS:
Blurred vision mm (mean±SD) |
20 | 58.7±22.8 | 34.7±25.6* | 28.8±28.5* | 17.7±26.5* | 19.3±27.6* |
| 4 | 54.5±31.8 | 47.5±31.7 | 37.3±32.5* | 25.7±28* | 26.1±27.9* | |
| VAS: photophobia mm (mean±SD) | 20 | 59.9±20.8 | 38.9±30.6* | 32.9±30.5* | 28.4±31.2* | 27.7±32.3* |
| 4 | 48.1±31.6 | 53.1±32.5 | 37.3±31.7 | 29.8±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.