EUCTR2017-002910-29-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 Eye Drops vs Xalatan® Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension. - ?herapeutic equivalence trial between two formulations of Latanoprost 50µg/ml Eye Drops
PHARMATHE0 个研究点目标入组 170 人开始时间: 2017年9月7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
- 170
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
- •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. Without treatment for open-angle glaucoma with IOP-lowering drugs for at least 4 weeks;
- •5. Best-corrected visual acuity =20 of 100 (Snellen) corresponding to logMAR of 0.7 ;
- •6. 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;
- •7. Patients with controlled arterial blood pressure according to the investigator’s opinion;
- •8. In case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures;
- •9. expected by the Investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
- •10. Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
- •11. 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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
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/angle-closure glaucoma;
- •4. 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. treatment with local or systemic corticosteroids;
- •12. any change in any systemic medication that affects IOP within the last 30 days (e.g. clonidine);
- •13. treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide);
- •14. a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial;
- •15. pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
- •16. current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •17. unwillingness or inability to comply with the clinical trial procedures;
- •18. unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- •19. who are legally incapacitated;
- •20. 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 tThe eye with higher IOP will be the study eye. If both eyes have the same IOP, then the Investigator has to select only one eye.
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