Clinical Trial: Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 Neurotrophic Keratitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up Period to Evaluate the Efficacy of a Formulation Containing Anti-oxid

Brief 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.