Patient Preference: Comparison of AZARGA/COSOPT for OAG/OH patients

• Research type

  Research Study

• Full title

  Patient Preference comparison of AZARGA versus COSOPT, in Patients with Open Angle Glaucoma or Ocular Hypertension.

• IRAS ID

  76361

• Sponsor organisation

  Alcon Research, Ltd.

• Eudract number

  RDG-10-251

• ISRCTN Number

  xx

• Research summary

  AZARGA and COSOPT are eye drops used for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently controlled using one single therapy. Since patient compliance is a significant factor for the success of treatment, the comfort of an eye drop is an important consideration. If the eye drop causes discomfort to the patient, it may not be taken as prescribed by the physician. This study will assess the patient preference of these two topical ocular medications.In this study the patient is blinded to the medication that they are recieving although they are aware that it is either AZARGA or COSOPT. Patients are randomised to one of two groups. Group 1 receive IMP A followed by B. Group 2 which receive IMP B followed by A.This is a 15 day study with 3 patient visits, Screening, Day 7 and Day 15. At Screening, subjects will receive one drop of AZARGA in one eye and one drop of COSOPT in the fellow eye. Subjects will be randomised in a 1:1 ratio to receive AZARGA or COSOPT (one drop in both eyes twice a day) during Period 1 (day 1 to day 7) for treatment 2 (day 9 to 15) randomised subjects will be crossed over to the opposite treatment. The dosage of AZARGA and COSOPT will be based on the marketing authorization for each product.Patients will be asked to complete an Ocular Discomfort Scale approximately 1 minute after receiving the morning dose on day 7 and day 15. A Preference and Adherence questionnaire will be completed on Day 15 after the ocular discomfort scale before exiting the trial.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0473

• Date of REC Opinion

  8 Jun 2011

• REC opinion

  Further Information Favourable Opinion