Clinical trial NCT02278614: Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
Official title: Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

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

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).

Primary outcomes:
measure: 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
timeFrame: Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont ferrand
country: France
facility: Laboratoires Thea
Study officials:
affiliation: Head of the Glaucoma Clinic
name: Ingeborg Stalmans, Professor
role: PRINCIPAL_INVESTIGATOR
References: