EUCTR2015-000160-34-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 Formulation of 0.2% Brimonidine/0.5% Timolol fixed-Combination Eye Drops solution free of Preservatives vs. Combigan® 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) - ?herapeutic equivalence trial between two formulations of 0.2% Brimonidine/0.5% Timolol
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Inclusion 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 and at least one hour apart;
- •-on treatment for open-angle glaucoma with IOP-lowering drugs for at least 24 weeks (and the last 4 weeks with Combigan®), or treated with Combigan® for ocular hypertension for the last 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 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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Exclusion Criteria:
- •-history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •- any uncontrolled systemic disease;
- •-narrow-angle/angle-closure glaucoma;
- •-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;
- •-ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine.
- •-treatment with local or systemic corticosteroids;
- •-receiving non-stable doses of any medication that could affect IOP within 30 days before the beginning of the clinical trial (e.g. clonidine);
- •-contraindication to beta-adrenoceptor antagonist therapy included, but not limited to current reactive airway disease, bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with a pace-maker, overt cardiac failure, cardiogenic shock
- •-history of severe or unstable and uncontrolled cardiovascular disease;
- •-history of depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans;
- •-history of severe hepatic or renal impairment;
- •-history of excessive consumption of alcohol or alcohol dependency during the last two years;
- •-history of illicit drug abuse ( e.g. phencyclidine,benzodiazepines, cannabinoids, amphetamines, barbiturates, cocaine and opiates);
- •-treatment with monoamine oxidase (MAO) inhibitor therapy (discontinued at least 14 days before);
- •-treatment with adrenergic augmenting psychotropic drugs/antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin);
- •-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.
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