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An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up to Evaluate the Efficacy of rhNGF 20 µg/ml vs Vehicle in Patients With Stage 2 and 3 Neurotrophic Keratitis

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Trial Profile

An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up to Evaluate the Efficacy of rhNGF 20 µg/ml vs Vehicle in Patients With Stage 2 and 3 Neurotrophic Keratitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Jun 2019

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At a glance

  • Drugs Cenegermin (Primary)
  • Indications Keratitis
  • Focus Therapeutic Use
  • Sponsors Dompe Spa

    • Most Recent Events

    • 22 Aug 2018 According to a Dompe media release, the U.S. Food and Drug Administration (FDA) has approved Oxervate (cenegermin-bkbj ophthalmic solution) for the treatment of neurotrophic keratitis (NK).
    • 22 Aug 2018 Topline data from this confirmatory study were presented at the 2017 Congress of the European Society of Ophthalmology, according to a Dompe media release.
    • 30 Jul 2018 Status changed from recruiting to completed.
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