EUCTR2017-002823-46-BE进行中（未招募）1 期
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.
aboratoires THÉA; Research and Development Department0 个研究点目标入组 143 人开始时间: 2019年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 143
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At Screening Visit:
- •1.1. Informed consent signed and dated
- •1.2. Patient aged =18 years old
- •1.3. 500 µm = central corneal thickness = 600 µm in both eyes
- •1.4. Both eyes with diagnosed open angle glaucoma or ocular
- •hypertension:
- •1.4.1 Initially treated and controlled for at least 6 months by dual
- •therapy of prostaglandin and timolol (fixed combination or not)
- •1.4.1.1. Both eyes with IOP = 18 mmHg
- •1.4.1.2. History of IOP insufficiently controlled with first-line monotherapy based on the following reasons:
- •No sufficient IOP reduction
- •Significant IOP reduction but progression of glaucoma (target IOP not reached)
- •1.4.1.3. Justification of an add-on IOP reduction with a combination of prostaglandin and timolol (fixed or not) 6 months after the switch from monotherapy to dual therapy (bitherapy)
- •1.4.2 Initially treated with first-line monotherapy for at least 6 months, insufficiently controlled and requiring a dual therapy (bitherapy)
- •At Randomisation Visit (Day 1) at 9h00:
- •1.5. Both eyes with 22 mmHg = IOP < 36 mmHg with asymmetry between eyes = 3 mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •Ophthalmic Exclusion Criteria in AT LEAST ONE EYE [2.1]
- •2.1.1 Funduscopy not performed or not available within 12 months
- •2.1.2 Visual field not performed or not available within 12 months
- •2.1.3 Advanced stage of glaucoma defined by at least one of the following criteria:
- •2.1.3.1 Absolute defect in the ten degrees central point of the visual field
- •2.1.3.2 Severe visual field loss : MD < -18 dB
- •2.1.3.3 Risk of visual field worsening as a consequence of participation in the study according to the investigator's best judgement
- •2.1.4 History of non-response to bimatoprost and/or timolol
- •2.1.5 Far Best Corrected Visual Acuity = +0.7 LogMar (e.g., =0.2 in decimal value or =20/100 Snellen equivalent or =50 ETDRS letters)
- •2.1.6 History of trauma, infection, clinically significant inflammation within the 3 previous months
- •2.1.7 Ongoing or known history of ocular allergy and/or uveitis and/or viral infection
- •2.1.8 Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment)
- •2.1.9 Presence of at least one severe objective sign among the following:
- •2.1.9.1 Conjunctival hyperaemia (Grade 5 / McMonnies scale)
- •2.1.9.2 Superficial punctate keratitis (Grade 4-5 / Oxford scale)
- •2.1.9.3 Blepharitis (Grade 3 / 0-3 scale)
- •2.1.10 Severe dry eye as assessed by the investigator
- •2.1.11 Corneal ulceration
- •2.1.12 Palpebral abnormalities incompatible with a good examination
- •2.1.13 Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination
- •Systemic/Non Ophthalmic Exclusion Criteria [2.2]
- •2.2.1 Uncontrolled diabetic patient
- •2.2.2 History of cardiac disorders (except controlled arterial hypertension)
- •2.2.3 Any ECG abnormalities considered clinically significant and/or contraindicating the prescription of Timolol (Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, or any relevant abnormalities) according to centralised medical review
- •2.2.4 Heart rate <50 bpm and/or systolic arterial blood pressure =90 mmHg
- •2.2.5 History of bronchopulmonary disorders (e.g. asthma, chronic obstructive pulmonary disease)
- •2.2.6 Known or suspected hypersensitivity to one of the components of the investigational product, run in treatment (sulphonamides) or auxiliary product (fluorescein, oxybuprocaine hydrochloride)
- •2.2.7 History of or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator judgement
- •Specific Exclusion Criteria Regarding Childbearing Potential Women[2.3]
- •2.3.1 Pregnancy or breast feeding
- •2.3.2 Childbearing woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch, double-barrier – i.e. condom associated with spermicide) and is not surgically sterilised
- •Exclusion Criteria Related to General Conditions [2.4]
- •2.4.1. Alcohol addiction and heavy smoker according to the investigator's judgement.
- •2.4.2. Inability of patient to understand the study procedures or to give informed consent
- •2.4.3. Non-compliant patient (e.g. not willing to attend a visit; way of life interfering with compliance)
- •2.4.4. Participation in this study at the same time as another clinical study
- •2.4.5. Participation in this study within the 4 weeks after the end of a previous clinical st
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