Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of
rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle
(formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is
intended as:
- complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer)
neurotrophic keratitis (NK) as measured by the central reading center using corneal
fluorescein staining,
- assessing the duration of complete healing,
- improvement in visual acuity and improvement in corneal sensitivity.