CTIS2023-506494-35-00进行中（未招募）1 期
A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-reference, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Combination of Brinzolamide 10mg/ml + Timolol 5mg/ml Eye Drops versus Azarga® 10mg/ml + 5mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension - BECRO/OV/BRINZOTIM
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •male or female, of any race and =18 years of age, diagnosed of unilateral or bilateral open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; either on treatment or treatment naïve, able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period, best-corrected visual acuity =20 of 100 corresponding to logMAR = 0.7 in both eyes, females who participate in the study are either unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control throughout the study; reliable contraception methods are considered the following: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation oral, implantable or injectable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence, expected by the investigator that IOP will remain controlled under 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 voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed
排除标准
- •history of chronic or recurrent inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis), ocular trauma within the past 6 months or ocular inflammation within the past 3 months or infections, severe central visual field loss (i.e., sensitivity =10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation) in either eye, treatment with local or systemic corticosteroids in non-stable doses in the last 30 days, treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide), any change in any systemic medication that could affect IOP within the last 30 days before the beginning of and during the study (e.g., clonidine, ß-blockers etc.), a history of, or current severe hepatic or renal impairment, a history of, or current hyperchloraemic acidosis, known hypersensitivity to sulphonamides, known hypersensitivity to beta-blockers, history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial, a history of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker, any uncontrolled systemic disease, current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease, severe allergic rhinitis, sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker, overt cardiac failure, 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 of another investigational device or drug trial(s), unwillingness or inability to comply with the clinical trial procedures, severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study, unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons, who are legally incapacitated, narrow-angle/angle-closure glaucoma, who are legally detained in an official institute, compromised cornea or corneal abnormalities that will preclude accurate IOP-reading with an applanation tonometer, clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye, intraocular surgery within the past 3 months, ocular laser surgery within the past 1 month, planned ocular surgery of any kind during study participation, extremely narrow or partially closed angle, cup/disk ratio >0.8
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia (CAH)MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850EUCTR2019-004873-17-DEeurocrine Biosciences, Inc.165
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional Health OutcomesOpioid-induced constipation in subjects with advanced illnessMedDRA version: 14.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-000854-30-GBSalix Pharmaceuticals Inc.254
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720