DuoTrav APS versus XALACOM® in OSDI Protocol v. 07Apr2009

• Research type

  Research Study

• Full title

  An Evaluation of the Ocular Surface Health in Subjects Using DuoTrav APS versus XALACOM® Eye Drops Solution.

• IRAS ID

  22388

• Contact name

  David Broadway

• Sponsor organisation

  Alcon Research Ltd

• Eudract number

  2009-010604-29

• ISRCTN Number

  Not yet available

• Research summary

  This research is conducted to determine if DuoTrav APS is better tolerated in the eye than XALACOM©. DuoTrav© (travoprost 40 micrograms/ml/ timolol 5 mg/ml Eye Drops, Solution) and XALACOM© (latanoprost 50 micrograms/ml / timolol 5 mg/ml Eye Drops, Solution) are both eye drops that are currently available by prescription for the treatment of high intra ocular pressure. In the marketed products DuoTrav© and XALACOM©, the preservative used to suppress the growth of germs is benzalkonium chloride (BAC). When used over very long periods, BAC in eye drops may cause signs of symptoms of eye discomfort. A new formulation of travoprost/ timolol eye drops: DuoTrav APS, in which the preservative (BAC) has been replaced by a new preservative called polyquaternium-1 is expected to be better tolerated in the eye, especially for the patients who are sensitive to BAC. It is also expected to show the same efficacy for lowering IOP as DuoTrav©. This study will involve about 700 patients worldwide and treatment duration will be 3 months. Study participants will be chosen from adult patients with open-angle glaucoma or ocular hypertension, who have been treated with XALACOM© for at least one month immediately prior to Visit 1. If they consent and are eligible, participants will be assigned by a procedure similar to tossing a coin to receive one of the 2 treatments above. They will then return after 90 days for eye examinations, eye pressure measurements and to complete questionnaires for assessment of the range of ocular surface symptoms. The sponsor of this study is Alcon research, Ltd. the maker of DuoTrav© and DuoTrav APS. Participants will be recruited at 70 sites worldwide, of which 3 will be UK NHS hospitals.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/48

• Date of REC Opinion

  24 Jun 2009

• REC opinion

  Further Information Favourable Opinion