Efficacy And Safety Study Of CYCLOKAT® In Dry Eye Disease Patients

• Research type

  Research Study

• Full title

  A MULTICENTER, RANDOMIZEDM DOUBLE-MASKED, 2 PARELLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH 6 MONTH OPEN-LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT® 1MG/ML (CICLOSPORIN/CYCLOSPORINE0 EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED)

• IRAS ID

  86014

• Contact name

  Francisco Figueiredo

• Sponsor organisation

  NOVAGALI PHARMA S.A.

• Eudract number

  2011-000160-97

• ISRCTN Number

  isrtn

• Research summary

  The purpose of the study is to demonstrate the superiority if CYCLOKAT© eye drops over vehilcle in patients with severe Dry Eye Disease and also to evaluate the ocular tolerability and overall ocular safety of CYCLOKAT©. Each patient will be randomly assigned to one of the two treatment groups (CYCLOKAT© or vehicle) using a 2:1 allocation ratio. The proposed 12 month study is a multicenter, randomized, double-masked, 2 parellel arm, vehicle controlled 6 month with a 6 month open label treatment safety follow-up period. At least 252 adult patients will be randomized in the study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1474

• Date of REC Opinion

  28 Nov 2011

• REC opinion

  Further Information Favourable Opinion