FDC tafluprost & timolol eye drops for patients with OAG/OH v1

• Research type

  Research Study

• Full title

  A phase III, randomized, double-masked 6-month clinical study to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual monotherapies in patients with open angle glaucoma or ocular hypertension

• IRAS ID

  70829

• Contact name

  Simon Longstaff

• Sponsor organisation

  Santen Oy

• Eudract number

  2010-022965-82

• Research summary

  This study is looking at the safety and effectiveness of new eye drops in the treatment of adults with ocular hypertension or open-angle glaucoma. The new product contains a preservative-free fixed-dose combination (FDC) of flurost and timolol. The FDC is being compared with monotherapies in patients whose condition is not sufficiently controlled by their current treatment with timolol or flurost eye drops alone. Eligible patients will be studied for approximately 8 months.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/H1005/8

• Date of REC Opinion

  23 Feb 2011

• REC opinion

  Further Information Favourable Opinion