EUCTR2009-011157-41-FR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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 (since at least one year) by a monotherapy of Xalatan® defined by:
- •Stable IOP (= 18 mmHg),
- •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
- •? and 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
- •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.
- •? for the visual field with:
- •A severe field loss.
- •A risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement.
- •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.
研究者
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