Demographic and clinical characteristics of patients included in the study
| rhNGF 20 µg/mL | rhNGF 4 µg/mL | P value | |
| Gender—N (%) | |||
| Female | 16 (80%) | 17 (85%) | NSS |
| Male | 4 (20%) | 3 (15%) | |
| Age | |||
| Years (mean±SD) | 48.4±12.0 | 55.9±14.8 | NSS |
| Race | |||
| Caucasian—N (%) | 20 (100%) | 20 (100%) | NSS |
| Body weight | |||
| kg (mean±SD) | 70.7±8.7 | 73.2±18.3 | NSS |
| Height | |||
| cm (mean±SD) | 167.7±8.2 | 165.1±7.3 | NSS |
| Vital signs | |||
| Blood pressure | |||
| Systolic/Diastolic blood pressure mm Hg (mean±SD) | 126.2±15.1/78.5±8.5 | 123.1±18/75.7±10 | NSS |
| Pulse rate beats/min (mean±SD) | 71.5±7.4 | 76.1±11 | NSS |
| Dry eye severity (DWES classification-N) | |||
| Mild | 0 | 0 | NSS |
| Moderate | 11 | 13 | |
| Severe | 8 | 5 | |
| Very severe | 1 | 2 | |
| Frequency of DED symptoms (SANDE scale) | |||
| Mean±SD | 55.3±27.3 | 52.8±23.2 | NSS |
| Severity of DED symptoms (SANDE scale) | |||
| Mean±SD | 59.7±29.2 | 60.1±29.6 | NSS |
| OSDI score | |||
| Mean±SD | 55.52±21.81 | 52.48±21.84 | NSS |
| Frequency of AT use | |||
| Number of daily administration (mean±SD) | 2.9±3.9 | 3.3±1.9 | NSS |
| BCVA | |||
| ETDRS number of letters (mean±SD) | 85.5±5.5 | 74.6±21.9 | NSS |
| Ocular surface staining | 5.2±2 | 5.9±2.7 | NSS |
| (NEI scale) total score cornea (mean±SD) total score | 8.1±3.5 | 6.8±2.7 | NSS |
| conjunctiva (mean±SD) total score (mean±SD) | 13.3±4.9 | 12.6±5.1 | NSS |
| Cornea sensitivity | |||
| (Cochet-Bonnet esthesiometer) mm (mean±SD) | 5.6±0.9 | 5.4±1.2 | NSS |
| Schirmer test type I | |||
| mm/5 min (mean±SD) | 4.1±3.3 | 5.2±3.7 | NSS |
| Break-up time | |||
| s (mean±SD) | 3.4±2 | 3.0±2.4 | NSS |
| Tear osmolarity (Tear Lab) | |||
| mOsm/L (mean±SD) | 313.6±13.7 | 313.6±16.1 | NSS |
AT, artificial tears; BCVA, best-corrected visual acuity; DED, dry eye disease; NEI, National Eye Institute; NSS, not statistically significant; OSDI, Ocular Surface Disease Index.
DEWS, Dry Eye Workshop
DEWS, Dry Eye Workshop.