Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients

Official Title
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Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: T2347
* Drug: Xalacom


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2347<br>T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops | Drug: T2347<br>* T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.<br>* Other names: Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops;|
| Active Comparator: Xalacom<br>Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops | Drug: Xalacom<br>* Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.<br>* Other names: Latanoprost 0.005% + Timolol 0.5% preserved eye drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye | the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye. Two relevant time points are considered for this primary criteria: D0 and Day 84. | Day 84 |