EUCTR2017-004524-29-GR进行中（未招募）1 期
Therapeutic Equivalence (non-inferiority), Randomized, Observer-blind, two Parallel Group, Clinical Trial for Comparing the Efficacy and Tolerability of a new Generic Preservative-Free Formulation of Latanoprost 50µg/ml/Timolol 5mg/ml Eye Drops vs Xalacom® Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension. - ?herapeutic equivalence trial between two formulations of Latanoprost/Timolol(50µg+5mg)/ml EyeDrops
PHARMATHE0 个研究点目标入组 210 人开始时间: 2018年1月24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
- 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
入选标准
- •1.male or female, of any race and =18 years of age;
- •2.diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension;
- •3.average IOP = 22 mmHg and = 35 mmHg measured at 08:00, 12:00 and 16:00 hours pre-treatment in at least one eye at day 0;
- •4.non-efficiently controlled IOP when treated either with prostaglandin analogues or b-blockers as monotherapy , according to investigator, at least 4 weeks before trial inclusion;
- •5.without treatment for open-angle glaucoma with IOP-lowering drugs for at least 4 weeks;
- •6.best-corrected visual acuity =20 of 100 (Snellen) corresponding to logMAR of 0.7;
- •7.no new systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on stable regimen for 30 days prior to the study and during the study;
- •8.patients with controlled arterial blood pressure according to the investigator’s opinion;
- •9.in case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures;
- •10.expected by the Investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
- •11.able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
- •12.willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1.history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •2.history of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema;
- •3.narrow-angle glaucoma, angle-closure glaucoma;
- •4.compromised cornea or corneal abnormalities that will preclude accurate IOP reading with an aplanation tonometer;
- •5.clinically significant or progressive retinal disease;
- •6.intraocular surgery within the past 3 months;
- •7.ocular laser surgery within the past 1 months;
- •8.best-corrected visual acuity = 20 of 100 (Snellen), corresponding to worse than 0.7 logarithm of minimal angle of resolution (logMAR) score;
- •9.cup/disk ratio >0.8;
- •10.current use of topical, ocular, nonsteroidal anti-inflammatory drugs;
- •11.history of reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease;
- •12.history of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, cardiogenic shock;
- •13.treatment with local or systemic corticosteroids;
- •14.ocular treatment with any prostamide, prostaglandin, alpha- adrenergic receptor agonist, ß-adrenergic blocker and pilocarpine;
- •15.any change in any systemic medication that affects IOP within the last 30 days (e.g. clonidine);
- •16.treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide);
- •17.history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial;
- •18.history of severe or unstable and uncontrolled cardiovascular disease;
- •19.pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
- •20.current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •21.unwillingness or inability to comply with the clinical trial procedures;
- •22.unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- •23.who are legally incapacitated;
- •24.who are legally detained in an official institute.
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