The purpose of study is to evaluate the safety and efficacy of rhNGF formulation containing anti-oxidant of recombinant human nerve growth factor (rhNGF) 20 µg/ml, eye drops solution versus vehicle containing anti-oxidant.
Neurotrophic Keratitis Stage 2 and 3
Drug: rhNGF 20µg/ml or Vehicle
The primary objective of this study is to demonstrate that rhNGF of 20 µg/ml containing the anti-oxidant is superior to vehicle containing the antioxidant as in the formulation of rhNGF and non inferior to rhNGF 20 µg/ml without antioxidant (NGF0212-REPARO data) in inducing the reduction of the greatest dimension of the PED or corneal ulcer in NK patients. The evaluation of efficacy is intended as:
Evaluation of Safety and tolerability of that rhNGF of 20 µg/ml containing the anti-oxidant.
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