EDNP

• Research type

  Research Study

• Full title

  A Multicentre, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop, Formulation with OPTIVETM Unit-Dose for 3 Months in Subjects with Dry Eye Disease

• IRAS ID

  111206

• Contact name

  Parwez Hossain

• Sponsor organisation

  Allergan (North America).

• Eudract number

  2012-002238-35

• ISRCTN Number

  not issued

• Research summary

  This is an Allergan sponsored study, in patients with Dry Eye Disease. Studies conducted in US, Canada, Australia, Asia & Europe have indicated that 5% to 30% of the population experiences dry eye signs and/or symptoms at some time during their lifespam. Approximately 60% of subjects are considered to have mild dry eye disease, and estimated 35% of subjects are considered to have moderate and 5% to have severe dry eye disease. Various treatments are available such as steroids, cyclosporine or artificial tears. Many subjects experience visual symptoms and/ or decrease in visual performances from their condition. Approximately 405 participants will be enrolled at 35 to 45 sites in order to have 352 participants at Day 90 in the Per Protocol population, assuming at least 87% of participants complete the study through to Day 90. This study will be comparing the safety and efficacy of Eye Drops New Platform Unit-Dose (EDNP UD) formulation with those of OPTIVETM Unit Dose (marketed drug). Participants will be asked to complete 4 types of self assessed questionnaires at various visits, including baseline, Day 7, 30, 60 and 90. Participants will be assigned according to a 1:1 treatment allocation to EDNP UD or OPTIVE UD. The randomization is stratified by Baseline OSDI questionnaire score (Ocular Surface Disease Index assessing the severity o dry eye disease). In addition there is a second stratification by the baseline Oxford Scheme staining score (staining of conjunctival surface to assess epithelial cell damage using a grading scale). The assigned study product will be dispensed to each randomized participant at their days 1, 30 and 60 visits. The participant will be trained to instil 1 to 2 drops in each eye, as required but at least 2 times daily. The main objective is to evaluate the safety and efficacy of DNP UD in participants with the signs and symptoms of dry eye disease. The study will be conducted in approximately 45 sites in Europe and other countries including the US & Israel. Patients will be recruited from hospital clinics and need to attend regular visits to receive treatment and be examined by their doctors. Taking part may or may not benefit a patient??s health. It is hoped that this study will contribute further information towards appropriate treatments for patients with Dry eye disease.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1326

• Date of REC Opinion

  4 Oct 2012

• REC opinion

  Further Information Favourable Opinion