A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

Trial Profile

A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Allergic conjunctivitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Santen S.A.S.
  • Most Recent Events

    • 04 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 24 Jul 2017 According to a European Medicines Agency media release, based on the data from this study, the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Verkazia (ciclosporin) in the European Union (EU) for the treatment of severe vernal keratoconjunctivitis (VKC).
    • 05 Aug 2015 Planned End Date changed from 1 Dec 2014 to 1 Apr 2016 as per ClinicalTrials.gov record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top