EUCTR2012-000044-10-ES进行中（未招募）1 期
Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Travoprost 40 µg/ml and Timolol 5 mg/ml Eye Drops vs. DuoTrav? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension - Non-inferiority of preservation-free travoprost fixed combination
OMNIVISIO0 个研究点目标入组 0 人开始时间: 2012年2月6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
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 patients, of any race and ?18 years of age;
- •?diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension;
- •?on treatment with an IOP-lowering prostaglandin analogue/beta blocker combination for at least 6 months;
- •?on treatment with an IOP ?21 mmHg on medication measured as a mean of both eyes at two measurements at least one hour apart;
- •?best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes;
- •?in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures;
- •?expected by the investigator that IOP would 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 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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •?pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogue/beta blocker combinations;
- •?a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •?narrow-angle/angle-closure glaucoma;
- •?clinically significant or progressive retinal disease;
- •?intraocular surgery within the past 6 months;
- •?ocular laser surgery within the past 3 months;
- •?a change in glaucoma therapy within 1 month before the screening visit;
- •?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;
- •?history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
- •?treatment with local or systemic corticosteroids;
- •?inability to discontinue the use of glucocorticoid medications;
- •?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 or a contraindication of ß-adrenergic receptor antagonists due to systemic disease;
- •?sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock
- •?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 and saving and transmission of pseudonymous medical data for clinical trial reasons;
- •?who are legally incapacitated,
- •?who are legally detained in an official institute.
研究者
相似试验
进行中（未招募）
1 期
Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of Travoprost 40 µg/ml Eye Drops vs. Travatan? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular HypertensioPrimary open angle glaucoma or intraocular hypertensionMedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2012-000026-22-ESOmnivision GmbH
进行中（未招募）
不适用
Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops vs. Xalacom? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular HypertensioPrimary open angle glaucoma or intraocular hypertensionMedDRA version: 14.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.0Level: LLTClassification code 10036719Term: Primary open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2011-005339-15-ESOmnivision GmbH
进行中（未招募）
不适用
This study will evaluate and confirm that the efficacy and tolerability of a New Preservative-free Formulation of Brimonidine 2 mg/ml Eye Drops is not worse compared to the marketed preservative-containing formulation Alphagan™ Eye Drops in Patients with Open Angle Glaucoma or Ocular HypertensioOpen angle glaucoma or ocular hypertension.MedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2013-003083-31-GROmniVision GmbH
进行中（未招募）
1 期
This study will evaluate and confirm that the efficacy and tolerability of the generic formulation Dorzo-Vision® sine Preservative-Free Eye Drops solution is not worse to the marketed preservative free formulation Trusopt® Eye Drops solution in Patients with Open Angle Glaucoma or Ocular Hypertension already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP=21 mmHg)Open angle glaucoma or ocular hypertensionMedDRA 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 disordersEUCTR2019-000913-35-GRBECRO (Cyprus) Ltd150
进行中（未招募）
1 期
Comparison of ADVAIR medication vs Salmeterol vs Albuterol in Asthma patients, assessing lung function and other measures of asthma control.AsthmaEUCTR2015-004865-10-Outside-EU/EEAGlaxoSmithKiline Research and Development LTD.547