Intraocular Pressure And Tolerability Study SPORT II

• Research type

  Research Study

• Full title

  Intraocular pressure and tolerability Study of Preserved Bimatoprost 0.01% (BIMMD) or Tafluprost Unit Dose Preservative Free 15microgram/ml (TUDPF) (Saflutan), in patients with Ocular hypertension or glaucoma suitable for prostaglandin therapy: A Randomized, single masked, 3 month cross-over, Investigator led, European multicentre Trial, II (SPORT II)

• IRAS ID

  185608

• Contact name

  Francesca Cordeiro

• Contact email

  m.cordeiro@ucl.ac.uk

• Sponsor organisation

  UZ Leuven

• Eudract number

  2014-004442-10

• Clinicaltrials.gov Identifier

  NCT02471105

• Duration of Study in the UK

  0 years, 7 months, 1 days

• Research summary

  First line treatment for glaucoma is mostly comprised of prostaglandin analogues, however there are differences regarding efficacy and tolerability; these can be related to the active compound and /or the preservative element, hence some prostaglandin analogues have been developed without preservatives. However, some compounds are dependent on preservatives to maintain their efficacy by enhancing penetration.
  The current study has been designed to investigate the efficacy and tolerability of two prostaglandin analogues: preservative-free tafluprost 15 microgram/ml versus bimatoprost 0.1 mg/ml which contains 0.02% of benzalkonium chloride (BAK) as a preservative. This cross-over study will shed new light on the efficacy and tolerability of two currently used prostaglandin analogues which have not been compared head to head so far, and on the relative impact of active ingredient versus BAK on tolerability and efficacy. This study will investigate the efficacy and safety of BUMD and TUDPF in a clinical setting and may influence these drugs’ future use in Europe.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  15/LO/1991

• Date of REC Opinion

  29 Feb 2016

• REC opinion

  Further Information Unfavourable Opinion