Evaluation of the safety and efficacy of PAD ciclosporin in dry eye patients

• Research type

  Research Study

• Full title

  A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 4 PARALLEL ARMS, CONTROLLED 6-MONTH TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF PAD CICLOSPORIN (CsA 0.06% AND 0.03%) OPHTHALMIC DISPERSION ADMINISTERED ONCE DAILY IN COMBINATION WITH LUBRICANT THERAPY AND A 3-MONTH POST-TREATMENT SAFETY FOLLOW-UP IN MODERATE TO SEVERE DRY EYE PATIENTS

• IRAS ID

  171789

• Contact name

  Mark Wilkins

• Contact email

  mail@markwilkins.co.uk

• Sponsor organisation

  DRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)

• Eudract number

  2015-000937-54

• Duration of Study in the UK

  years, 17 months, days

• Research summary

  This is 4-arms randomized and controlled study in moderate to severe dry eye patients, for which two doses of PADciclo (preservative free formulation) will be administered once daily for 6 months in combination with lubricant therapy and compared to artificial tears (the current standard of treatment) and the vehicle. This study will involve around 264 patients in Denmark, Netherlands, Portugal, Norway, Spain, Austria, Switzerland and United Kingdom
  It will consist of a 14 days run-in period followed by a 6 months treatment phase and 3-month follow-up period.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  15/LO/0781

• Date of REC Opinion

  3 Aug 2015

• REC opinion

  Further Information Favourable Opinion