Changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma

• Research type

  Research Study

• Full title

  A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/ timolol 0.5%).

• IRAS ID

  174903

• Contact name

  Rupert Bourne

• Contact email

  rb@rupertbourne.co.uk

• Sponsor organisation

  Santen O.Y.

• Eudract number

  2014-005273-37

• Duration of Study in the UK

  1 years, 3 months, 30 days

• Research summary

  A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)

  This is a research study (clinical trial) investigating a new ocular (eye) pressure lowering product called tafluprost-timolol fixed dose combination (Taptiqom®) in patients/participants with ocular hypertension or open-angle glaucoma. The first European marketing authorisation of Taptiqom® was received on 30th October 2014. Taptiqom® does not contain any preservatives.
  
  The purpose of the study is to find out if changes in ocular signs or symptoms occur when patients are switched from Ganfort® eye drops (combination of prostaglandin bimatoprost 0.03% and timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015% and timolol 0.5%).

  Approximately 120 participants from several European countries will participate in this study. The study treatment period is 12 weeks and there would be 5 visits. This treatment period would be followed by a post-study period of 1-3 weeks.

  Participants would be asked to sign a consent form and undergo a screening test to determine their eligibility to take part in the study. Only patients that have been regularly using glaucoma medication Ganfort® for at least 4 weeks and meet other inclusion criteria would be eligible for this study.

  Some of the procedures/assessments that the participants would undergo include the following:
  • Questions about any current or previous illnesses, including details of any medication and any other medication currently being taking will be asked
  • Ocular examinations performed
  • Urinary pregnancy testing for women of childbearing potential

  It is possible that participants taking part in this study may find no benefit to them, but the information obtained from this study will help in future to improve the treatment of people with glaucoma or ocular hypertension.

  Santen Oy, a pharmaceutical company based in Finland is the study Sponsor.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  15/EE/0273

• Date of REC Opinion

  8 Sep 2015

• REC opinion

  Further Information Favourable Opinion