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

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

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

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).