Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients. Phase III study, international, multicentre, randomised, investigator-masked, 2 parallel groups, versus reference product, in 360 evaluable patients treated for 3 months

INTERVENTION: Product Name: T2345 Product Code: T2345 Pharmaceutical Form: Eye drops* INN or Proposed INN: LATANOPROST CAS Number: 130209‐82‐4 Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 0.005‐ Trade Name: Xalatan Pharmaceutical Form: Eye drops* INN or Proposed INN: LATANOPROST CAS Number: 130209‐82‐4 Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 0.005‐ CONDITION: The study population will be suffering from open angle glaucoma or hypertension. ; MedDRA version: 12.0 Level: LLT Classification code 10030348 Term: Open angle glaucoma ; MedDRA version: 12.0 Level: LLT Classification code 10030043 Term: Ocular hypertension PRIMARY OUTCOME: Main Objective: To assess the efficacy on IOP of T2345 (latanoprost 0.005% unpreserved eye drops) versus Xalatan (latanoprost 0.005% preserved eye drops) Primary end point(s): Change in IOP at 9.00 am (± 1 hour) between Day 0 (D0, baseline) and D84 (or the last attended visit after baseline) in the worse eye (or in the right eye in case of no IOP difference between both eyes). Secondary Objective: Change in IOP between D0 and D84 in the controlateral eye (if applicable).; Change in IOP between D0 and D15 in the worse eye and in the controlateral eye (if applicable).; Change in IOP between D0 and D42 in the worse eye and in the controlateral eye (if applicable).; Global efficacy assessed by the investigator on D15, D42 and D84.; Objective ocular signs at the Slit Lamp Examination at D15, D42 and D84.; Ocular symptoms upon instillation at D15, D42 and D84.; Other ocular symptoms at D15, D42 and D84.; Best far corrected visual acuity at D84.; Visual Field test, if performed at D84.; Fundunscopy, if performed at D84.; Global tolerance assessed by the investigator at D15, D42 and D84.; Global tolerance assessed by the patient at D15, D42 and D84.; Adverse events recorded from D0 and throughout the study. INCLUSION CRITERIA: Patients will be eligible for inclusion if all these criteria are respected: At Selection Visit: Signed and dated informed consent, Male or female aged from = 18 to = 90 years old, Association of the following criteria for the eligible eye(s): Chronic primary open angle glaucoma or chronic ocular hypertension Already treated and controlled (for at least one year) by a monotherapy of Xalatan® defined by: Stable IOP (= 18 mmHg) AND Stable visual field defined by two available visual field: the penultimate visual field performed within the last 18 months the last visual field performed within the last 6 months with an interval of at least 6 months between both visual fields. Corneal thickness = 510 µm and = 560 µm. At Inclusion Visit: IOP: