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

Launched by LABORATOIRES THEA · Oct 29, 2014

Keywords

ClinConnect Summary

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

Gender

ALL

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).