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A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 2 PARALLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH A 6 MONTH OPEN LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED)

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Trial Profile

A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 2 PARALLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH A 6 MONTH OPEN LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2019

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At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms SANSIKA
  • Sponsors Santen S.A.S.

    • Most Recent Events

    • 04 Nov 2015 According to a Santen Pharmaceutical media release, the National Institute for Health and Care Excellence (NICE) issued positive Final Appraisal Determination (FAD) recommending the use of IKERVIS (ciclosporin) for the treatment of severe keratitis in adult patients with dry eye disease based on data from this study.
    • 03 Nov 2014 New trial record

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