efficacy and safety assessment of t2347 versus xalacom® in ocular hypertensive or glaucomatous patients

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the objective of the study is to assess the efficacy and safety of t2347 (latanoprost 0.005% + timolol 0.5% unpreserved eye drops) versus xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by xalacom® or generics (fixed combination latanoprost 0.005% + timolol 0.5% preserved eye drops).

phase iii, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 x 97 evaluable patients

Eligibility criteria:
inclusion criteria: * signed and dated informed consent, * male or female aged \> 18 years old, * both eyes with open angle glaucoma or ocular hypertension already treated and controlled by xalacom® or generics (fixed combination latanoprost 0.005% + timolol 0.5% preserved eye drops) since at least 2 months. * iop ≤ 18 mmhg in both eyes * history of iop insufficiently controlled with first-line monotherapy based on the investigator judgement (e.g. non reaching the target iop) * history of an add-on iop reduction with xalacom® or generics (fixed combination latanoprost 0.005% + timolol 0.5% preserved eye drops) in comparison with first-line treatment * corneal thickness ≥ 500 μm and ≤ 600 μm in both eyes. exclusion criteria: * ophthalmic exclusion criteria (in either eye) * fundoscopy, vf not performed or not available within the 6 months before inclusion visit. * significant worsening according to the two last vf (minimum 6 months between these 2 vf) * advanced stage of glaucoma: * best far corrected visual acuity ≤ 1/10. * history of trauma, infection, clinically significant inflammation within the 3 months before inclusion visit. * ongoing or known history of ocular seasonal and perennial allergy (sac, pac) and/or uveitis and/or viral infection. * presence of at least one severe objective sign among the following: * hyperaemia (grade 5) * superficial punctate keratitis (grade 3) * blepharitis (grade 3) * severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day). * corneal ulceration. * palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation. * history of corneal refractive surgery. * any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination. systemic/non ophthalmic exclusion criteria * non-controlled diabetic patient. * reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. * sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, cardiogenic shock. * heart rate \<50 bpm, systolic arterial blood pressure≤ 90 mm hg * known or suspected hypersensitivity to one of the components of the study product. * any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc... and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study. specific exclusion criteria for women * pregnancy, lactation. * childbearing potential woman who is not using a reliable method of contraception exclusion criteria related to general conditions * inability of patient to understand the study procedures and thus inability to give informed consent. * non-compliant patient * participation in another clinical study with investigational drug within the last 3 months. * already included once in this study. * patients being institutionalised because of legal or regulatory order, inmates of psychiatric wards, prison or state institutions, and employees of the study sites or of the sponsor's company. * ward of court. * patient not covered by government health care scheme in the country (if applicable).