EUCTR2013-005222-29-BE进行中（未招募）不适用
Efficacy and Safety assessment of fixed combination unpreserved Latanoprost eye drops and Timolol 0.5% (T2347) versus Xalacom® in ocular hypertensive or glaucomatous patients.Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients
aboratoires THÉA0 个研究点目标入组 210 人开始时间: 2014年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •Patient will be eligible for inclusion in this study if all these criteria are respected at the inclusion visit:
- •-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 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.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Ophthalmic exclusion criteria (in either eye)
- •-Fundoscopy not performed or not available within the 6 months before inclusion visit.
- •-Visual field (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:
- •Absolute defect in the ten degrees central point of the visual field.
- •Severe visual field loss according to the investigator’s best judgement.
- •Risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement.
- •-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 or corneal refractive surgery.
- •The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general conditions and exclusion criteria related to previous and concomitant medications/ non-product therapies.
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