EUCTR2019-000913-35-GR进行中（未招募）1 期
A Randomized, Observer-blind, two Parallel Group, Multi-center, Clinical Trial for Comparing the Efficacy and Tolerability of Dorzo-Vision® sine Preservative-Free Eye Drops vs. Trusopt® Preservative-Free Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension, already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP=21 mmHg) - ?herapeutic equivalence trial between two formulations of Dorzolamide 20mg/ml eye drops solution
BECRO (Cyprus) Ltd0 个研究点目标入组 150 人开始时间: 2019年5月2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
- 150
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
- •-Male or female, of any race and =18 years of age;
- •-Diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension;
- •-IOP =21 mmHg measured as the mean of two measurements in each eye;
- •-On treatment with IOP-lowering drugs for open-angle glaucoma for at least 24 weeks, or for ocular hypertension for at least 4 weeks;
- •-Best-corrected visual acuity =20 of 100 corresponding to logMAR of =0.7 at both eyes;
- •-In case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control (contraception) methods; Reliable contraception methods are considered the following:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner
- •sexual abstinence
- •-Expected by the investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
- •-Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
- •-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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •-history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •-any uncontrolled systemic disease
- •-narrow-angle/angle-closure glaucoma;
- •-compromised cornea or corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer
- •-clinically significant or progressive retinal disease;
- •-intraocular surgery within the past 6 months;
- •-ocular laser surgery within the past 3 months;
- •-best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8;
- •-treatment with local or systemic corticosteroids in non-stable doses in the last 30 days;
- •-treatment with oral carbonic anhydrase inhibitors
- •-change in any systemic medication that could affect IOP (e.g. clonidine, b-blockers etc.) within 30 days before the beginning of the study;
- •- a history of severe hepatic, or renal impairment (creatinine clearance < 30 ml/min);
- •- a history of hyperchloraemic acidosis.
- •- known hypersensitivity to sulphonamides
- •-a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial;
- •-pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
- •-current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •-unwillingness or inability to comply with the clinical trial procedures;
- •-unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- •-who are legally incapacitated;
- •-who are legally detained in an official institute.
- •Patients requiring bilateral IOP-reducing therapy are treated in both eyes, but only the eye that fulfils all of the inclusion criteria and none of the exclusion criteria will be the study eye. In case that both eyes fulfil all of the inclusion criteria and none of the exclusion criteria, then the Investigator has to select only one eye.
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