Travoprost APS versus Xalatan® in OSDI Protocol v.16Mar2009

• Research type

  Research Study

• Full title

  An Evaluation of the Ocular Surface Health in Subjects Using Travoprost APS Eye Drops Solution Versus Xalatan® Eye Drops Solution.

• IRAS ID

  17240

• Eudract number

  2009-010606-10

• ISRCTN Number

  requested

• Research summary

  This research study is conducted to determine if Travoprost APS is better tolerated in the eye than XALATAN©. TRAVATAN© (travoprost 40 micrograms/ml eye drops, solution) and XALATAN© (latanoprost 50 micrograms/ml eye drops, solution) are both eye drops that are currently available by prescription for the treatment of high intraocular pressure. In the marketed products TRAVATAN© and XALATAN©, the preservative used to suppress growth of germs is benzalkonium chloride (BAC). When used in the eye over very long periods, BAC in eye drops may cause signs of symptoms of eye discomfort. A new formulation of travoprost eye drops: Travoprost APS, in which, the preservative (BAC) has been replaced by a new preservative called Polyquad is expected to be better tolerated in the eye, especially for the patients who are sensitive to BAC.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 TRAVATAN©. 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 XALATAN© for at least one month immediately prior to Visit 1. Patients who consent to take part will have a comprehensive eye examination to ensure that they meet all criteria for the study. If they qualify, 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 42 and 90 days for eye examinations, eye pressure measurements, and to complete Ocular Surface Disease Index questionnaire for assessment of the range of ocular surface symptoms. The sponsor of this study is Alcon Research, Ltd. the maker of TRAVATAN© and Travoprost APS. Participants will be recruited at 70 sites worldwide, of which 4 will be UK NHS hospitals.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0803/83

• Date of REC Opinion

  9 Jul 2009

• REC opinion

  Further Information Favourable Opinion