Status:
COMPLETED
Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
Lead Sponsor:
Laboratoires Thea
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 initi...
Detailed Description
Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT02278614
Start Date
December 1 2014
End Date
November 1 2015
Last Update
April 28 2017
Active Locations (1)
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1
Laboratoires Thea
Clermont-Ferrand, France, 63017