EUCTR2009-011157-41-ES进行中（未招募）1 期
Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients.Phase III study, international, multicentre, randomised, investigator-masked, 2 parallel groups, versus reference product, in 360 evaluable patients treated for 3 months.
aboratoires Théa0 个研究点目标入组 400 人开始时间: 2009年8月13日最近更新:
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
- 400
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
- •Patients will be eligible for inclusion if all these criteria are respected:
- •At Selection Visit:
- •Signed and dated informed consent,
- •Male or female aged from ? 18 to ? 90 years old,
- •Association of the following criteria for the eligible eye(s):
- •Chronic primary open angle glaucoma or chronic ocular hypertension
- •Already treated and controlled (for at least one year) by a monotherapy of
- •Xalatan® defined by:
- •Stable IOP (? 18 mmHg) AND
- •Stable visual field defined by two available visual field:
- •the penultimate visual field performed within the last 18 months
- •the last visual field performed within the last 6 months
- •with an interval of at least 6 months between both visual fields.
- •Corneal thickness ? 510 µm and ? 560 µm.
- •At Inclusion Visit:
- •IOP < 34 mmHg in BOTH eyes AND
- •IOP ? 22 mmHg in the eligible eye(s).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients fulfilling at the selection visit ONE OR MORE of the following non inclusion criteria will not be included in the study:
- •Ophthalmic non-inclusion criteria (in either eye):
- •Any secondary ocular hypertension (such as congenital glaucoma, closed-angle glaucoma, secondary glaucoma, glaucoma after cataract surgery,?).
- •Any severe glaucoma defined by:
- •an advanced cupping AND/OR
- •for the visual field:
- •A severe field loss AND/OR
- •A risk of visual field worsening as a consequence of participation
- •in the trial according to the investigator?s best judgement AND/OR
- •An absolute defect in the ten degree central point.
- •Best far corrected visual acuity ? 1/10.
- •Known history of ocular allergy and/or blepharitis and/or uveitis.
- •History of traumatism, infection, ocular inflammation within the 3 months before the selection visit.
- •History of refractive surgery.
- •Severe dry eye (for example, clinically relevant superficial punctuate keratitis, epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations/day).
- •Any abnormality preventing accurate assessment e.g. reliable applanation tonometry, visual field examination.
- •Systemic/non ophthalmic non-inclusion criteria
- •General history:
- •Non controlled asthma.
- •Any medical or surgical history, disorder or disease such as acute or chronic
- •severe organic disease: hepatic, endocrine, neoplasic, 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.
- •Known allergic hypersensitivity history to one of the components of the study medications or to test products.
- •Specific non-inclusion criteria for women:
- •Pregnancy, lactation.
- •Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) or women not hysterectomised, menopaused or surgically sterilized.
研究者
相似试验
进行中（未招募）
1 期
Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients.Phase III study, multicentre, international, randomised, investigator-masked, 2 parallel groups, versus Reference product, in 400 evaluable patients treated during 3 months.The study population is suffering from glaucoma.MedDRA version: 9.1Level: LLTClassification code 10018304Term: GlaucomaMedDRA version: 9.1Level: PTClassification code 10018304Term: GlaucomaEUCTR2009-011157-41-FRlaboratoires théa400
进行中（未招募）
不适用
Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan in ocular hypertensive or glaucomatous patients. - NDEUCTR2009-011157-41-ITABORATORIES THEA400
进行中（未招募）
不适用
Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan® in ocular hypertensive or glaucomatous patients.Phase III study, international, multicentre, randomised, investigator-masked, 2 parallel groups, versus reference product, in 360 evaluable patients treated for 3 months.The study population will be suffering from open angle glaucoma or hypertension.MedDRA version: 12.0Level: LLTClassification code 10030348Term: Open angle glaucomaMedDRA version: 12.0Level: LLTClassification code 10030043Term: Ocular hypertensionEUCTR2009-011157-41-BEaboratoires Théa400
进行中（未招募）
不适用
Efficacy and Safety assessment of LT2345 unpreserved eye drops versus Xalatan in ocular hypertensive ou glaucomatous patients.PHase III study, international, multicentre, randomised, investigator masked, 2 parallel groups, versus reference product in 360 evaluable patents treated for 3 months.The study population is suffering from glaucoma.EUCTR2009-011157-41-PTaboratoires Thea400
已完成
2 期
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular HypertensionPrimary Open Angle GlaucomaNCT01494753Laboratoires Thea30