EUCTR2014-002576-91-GR进行中（未招募）不适用
Therapeutic Equivalence (non-inferiority), Randomized, Observer-blind, two Parallel Group, Clinical Trial for Comparing the Efficacy and Tolerability of a new Generic Formulation of Travoprost 40µg/ml Eye Drops Free of Preservatives vs. TRAVATAN® 40µg/ml 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 Travoprost 40µg/ml Eye Drops
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •In order to be included, subjects will have to meet all of the following criteria:
- •-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 for open-angle glaucoma with IOP-lowering drugs for at least 24 weeks (and the last 4 weeks with TRAVATAN® 40µg/ml), or treated with TRAVATAN® 40µg/ml for ocular hypertension for the last four 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 measures;
- •-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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •In order to be included, subjects will have to meet none of the following criteria:
- •-history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •-history of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema
- •-narrow-angle/angle-closure glaucoma;
- •-corneal abnormalities that will preclude accurate IOP reading with an aplanation 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;
- •-current use of topical, ocular, nonsteroidal anti-inflammatory drugs
- •-treatment with local or systemic corticosteroids;
- •-not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
- •-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(s) that fulfil(s) all of the inclusion criteria and none of the exclusion criteria are designated as clinical trial eye(s). An eye not meeting all inclusion criteria but having none of the exclusion criteria may be treated with the clinical trial drug at the discretion of the investigator.
研究者
相似试验
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a New Preservative-free Generic Formulation of 0.2% Brimonidine/0.5% Timolol fixed-Combination Eye Drops solution in single dose container is not worse to the marketed preservative-containing formulation Combigan®Eye Drops solution in Patients with OpenAngle Glaucoma or Ocular Hypertension already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP=21 mmHg)Open angle glaucoma or ocular hypertension.MedDRA version: 18.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2015-000160-34-GROmniVision GmbH
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a new Preservative-free Generic Formulation of Latanoprost 50µg/ml Eye Drops solution in multiple dose container is not worse to the marketed preservative-containing formulation Xalatan®Eye Drops solution in Patients with Open Angle Glaucoma or Ocular HypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002910-29-GRPHARMATHE170
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of a new preservative-free generic formulation of Latanoprost l/Timolol (50µg+5mg)/ml Eye Drops solution is not worse to the marketed preservative-containing formulation Xalacom® Eye Drops solution in Patients with Open Angle Glaucoma or Ocular HypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disordersMedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disordersMedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disordersEUCTR2017-004524-29-GRPHARMATHE210
进行中（未招募）
1 期
This clinical trial will evaluate and confirm that the efficacy and tolerability of a Generic formulation of Vaginal Ovule containing Clindamycin 100 mg/ovule is not worse to the innovator marketed product Dalacin® 100 mg Vaginal Ovules (Pfizer©) in patients with Bacterial VaginosisBacterial VaginosisEUCTR2016-004292-41-GRVerisfield (UK) Ltd., Greek branch292
进行中（未招募）
1 期
A Study for Comparing a Generic Combination of Brinzolamide and Timolol Eye Drops versus Azarga® Eye Drops in the Treatment of Patients with GlaucomaCTIS2023-506494-35-00OmniVision GmbH234