192024-050: Bimatoprost/Timolol PF compared with Ganfort

• Research type

  Research Study

• Full title

  A Multicenter, Double-masked, Randomized, Parallel Study of the Safety and Efficacy of Bimatoprost 0.03%/Timolol 0.5% Preservative-free Ophthalmic Solution Compared with GANFORT® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) Once Daily for 12 weeks in Patients with Glaucoma or Ocular Hypertension.

• IRAS ID

  62267

• Contact name

  Kin Sheng Lim

• Sponsor organisation

  Allergan LTD

• Eudract number

  2010-021507-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  NCT01177098

• Research summary

  GANFORT©, a fixed combination of bimatoprost 0.03% and timolol 0.5% (hereafter referred to as GANFORT), is approved in more than 45 countries worldwide including European countries for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (OHT). Bimatoprost and timolol, each as an single agent, are approved worldwide for the lowering of elevated IOP and have well established safety and efficacy profiles as monotherapies in the treatment of patients with glaucoma or ocular hypertension. Allergan is developing a preservative-free formulation of GANFORT that differs from GANFORT only in that benzalkonium chloride (BAK) has been removed. It is not anticipated that the removal in the preservative-free (PF) formulation of the small amount of BAK, 50 ppm, will have any clinically significant effect on the IOP-lowering effect. The removal of preservative may improve tolerability in some patients while maintaining IOP-lowering efficacy. A single-use container of PF formulation is expected to provide convenience for patient use. The specific purpose of this study is to evaluate the safety and efficacy of bimatoprost 0.03%/timolol 0.5% Preservative-free ophthalmic solution compared to GANFORT in patients with glaucoma or ocular hypertension. A general purpose of the study is to use the study data to develop a better understanding of diseases capable of being treated with bimatoprost 0.03%/timolol 0.5% PF ophthalmic solution or similar drugs, and to assist in the designing of future clinical trials in evaluating the potential for future development of the product.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/99

• Date of REC Opinion

  17 Nov 2010

• REC opinion

  Further Information Favourable Opinion