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NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis

Leonardi A.; Pisella P.-J.; Benítez-del-Castillo J.M.; Amrane M.; Ismail D.; Doan S.; Bremond-Gignac D.


  • 2023
  • Clinical Therapeutics
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  • Therapeutic Area

    Front of the eye (FOTE)

  • Categories

    Clinical development

  • Affiliations

    Department of Neuroscience, University of Padua, Padua, Italy; Department of Ophthalmology, Tours University Hospital, Université François Rabelais, Hôpital Bretonneau, Tours, France; Department of Ophthalmology, Hospital Clinico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clinico San-Carlos (IdISSC), Madrid, Spain; Clínica Rementería, Madrid, Spain; Santen SAS, Évry-Courcouronnes, France; Department of Ophthalmology, Fondation A de Rothchild, Paris, France; University Hospital Necker-Enfants Malades, Assistance Publique–Hôpitaux de Paris, Paris, France; Rare Eye Disease Center (OPHTARA), Paris Cite University, Paris, France

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Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (NOVATIVE): A Phase II/III, Multicenter, Double-masked, Randomized Study of 0.05% Cyclosporine A and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Vernal Keratoconjunctivitis

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Document number: NP-No product-EMEA-0110
Date of preparation: February 2022