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.

Detailed Summary:
Sponsor: Dompé Farmaceutici S.p.A

Current Primary Outcome: Complete healing of the PED or corneal ulcer [ Time Frame: Week 8 ]

Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement in visual acuity [ Time Frame: Week 8 ]

  • Mean change in BCDVA from baseline to Week 8. Analysis of variance will be used to compare the mean change between treatment groups.
  • Percentage of patients that achieve a 15 letter gain in BCDVA at 4, 6 and 8 weeks. Treatment will be compared at each time point by means of Chi-square test.


Original Secondary Outcome: Improvement in visual acuity [ Time Frame: Week 8 ]

improvement in visual acuity at the end of the 8 week controlled treatment period


Information By: Dompé Farmaceutici S.p.A

Dates:
Date Received: August 26, 2014
Date Started: February 2015
Date Completion: September 2016
Last Updated: August 13, 2015
Last Verified: August 2015