T2347(Latanoprost/Timolol) vs Xalacom® in glaucoma/ocular hypertension
Research type
Research Study
Full title
Efficacy and Safety assessment of fixed combination unpreserved Latanoprost eye drops and Timolol 0.5% (T2347) versus Xalacom® in ocular hypertensive or glaucomatous patients.
IRAS ID
156860
Contact name
Jonathan Clarke
Contact email
Sponsor organisation
Laboratoires THÉA
Eudract number
2013-005222-29
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Are unpreserved eye drops containing latanoprost and timolol (T2347)as effective, in treating ocular hypertension or glaucoma, as preserved eye drops containing the same active ingredients (Xalacom®)?
This study assesses the efficacy and safety of an unpreserved single unit-dose (SUD) eye drop solution containing latanoprost 0.005% and timolol 0.5% (T2347). It will be conducted in patients with ocular hypertension or open angle glaucoma, who are currently being treated with a preserved multi-dose (MD)eye drop solution containing the same fixed combination of active ingredients (Xalacom®, or another marketed brand). The study compares once-daily treatment of the unpreserved and preserved eye drops for a period of 3 months. Preservatives can cause irritation to the surface of the eye, so the study will assess the signs and symptoms caused by the different treatments; it will also compare their effectiveness and safety. The study is being conducted in 210 patients in Ophthalmology departments of hospitals in Belgium, France, Germany, Spain and the UK. After entry into the study, patients are required to attend 3 visits to their Ophthalmologist during which routine eye investigations will be conducted, including measurement of intraocular pressure, slit-lamp (microscope) eye examination, eyesight test and fluorescein stain of surface of the eye to detect any damaged cells. Patients will also be asked to report any adverse event that they have suffered. At the end of the study, patients will be prescribed treatment for their condition by their Ophthalmologist.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1923
Date of REC Opinion
23 Dec 2014
REC opinion
Further Information Favourable Opinion