Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: T2347; Xalacom
Intervention description: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.; Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Intervention MeSH terms: Timolol; Ophthalmic Solutions; Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

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).