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
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 03 Aug 2017
At a glance
- Drugs Ciclosporin (Primary)
- Indications Allergic conjunctivitis
- Focus Registrational; Therapeutic Use
- Sponsors Santen S.A.S.
- 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.
- 05 Aug 2015 Planned primary completion date changed from 1 Dec 2014 to 1 Feb 2016 as per ClinicalTrials.gov record..