Table 3.
Adverse events in Cohort 2
Subjects | Concentration (one drop tid for 1 day; μg/ml) | Ocular AEs reported (no. of patients; severity) | Systemic AEs reported |
---|---|---|---|
6 rhNGF | 20 | Blurred vision (moderate) and pressure sensation (mild), left eye; increased fluorescein staining (mild–moderate), both eyes (n = 1) | None |
6 rhNGF | 60 | None | None |
6 rhNGF | 180 | Eye irritation (n = 1; mild); photophobia (n = 1; mild) | Ligament sprain (n = 1; severe) |
6 placebo | Blurred vision (moderate, n = 1); eyelid irritation (moderate n = 1) | Headache (mild, n = 2); arthritis (mild, n = 1); depression (moderate, n = 1) |
tid three times daily, AEs adverse events, rhNGF human recombinant nerve growth factor