EUCTR2015-005314-29-ES进行中（未招募）1 期
Randomized, open-label, two parallel group clinical trial, conducted under blinding evaluator conditions to compare the efficacy and tolerability of preservative-free formulation of Latanoprost 50µg/ml eye drops vs. Xalatan in patients with open-angle glaucoma or hypertension ocular.
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
- •Patients being
- •-male or female, 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 for at least 6 months
- •-on treatment with an IOP ?21 mmHg measured as the 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 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 126
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •-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;
- •-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, 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）
不适用
Randomized, two paralel groups, open clinical trial stratified by severity to stimate the cost-effectivity of surgical vs corticosteroid injection treatment on carpal tunnel syndromeMedDRA version: 14.1Level: PTClassification code 10007697Term: Carpal tunnel syndromeSystem Organ Class: 10029205 - Nervous system disordersCarpal tunnel syndromeEUCTR2013-000873-56-ESFederico Diaz González70
进行中（未招募）
1 期
A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic patientsMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002266-45-NLGlaxoSmithKline Research & Development Ltd432
进行中（未招募）
1 期
A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic patientsMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002266-45-DEGlaxoSmithKline Research & Development Ltd437
进行中（未招募）
1 期
A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic patientsAsthmaMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-002266-45-FRGlaxoSmithKline Research & Development Ltd600
进行中（未招募）
1 期
A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic patients.MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2017-002266-45-ESGlaxoSmithKline, S.A.600