NCT02278614已完成3 期
Efficacy and Safety Assessment of Fixed Combination Unpreserved Latanoprost Eye Drops and Timolol 0.5% (T2347) Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/
- •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).
研究组 & 干预措施
T2347
Experimental
T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops
干预措施: T2347 (Drug)
Xalacom
Active Comparator
Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
干预措施: Xalacom (Drug)
结局指标
主要结局
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
时间窗: Day 84
the non-inferiority of T2347 unpreserved eye drops 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. Two relevant time points are considered for this primary criteria: D0 and Day 84.
次要结局
未报告次要终点
研究者
研究点 (1)
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