CTIS2023-507285-24-00招募中1 期
on-inferiority Clinical Trial for Comparing the Efficacy and Tolerability of a new fixed-Combination Generic Formulation of Brimonidine 0.2%/Timolol 0.5% eye drops, solution in single-dose containers vs Combigan® eye drops, solution in Patients with Open Angle Glaucoma or Ocular Hypertension - BECRO/PS/ETHRA
Becro (Cyprus) Limited0 个研究点目标入组 180 人开始时间: 2023年11月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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., 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., Diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension, Average IOP = 22 mmHg and = 35 mmHg measured at 08:00, 12:00 and 16:00 hours pre-treatment in at least one eye at day 0., Without treatment for open-angle glaucoma with IOP-lowering drugs, for at least 4 weeks., Best-corrected visual acuity =20 of 100 (Snellen) corresponding to logMAR of =0.7., No new systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on stable regimen for 30 days prior to the study and during the study., Patients with controlled arterial blood pressure according to the investigator’s opinion., 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 with the new treatment without optic nerve damage or progression of visual field loss;
排除标准
- •?istory 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;, Current use of topical, ocular, nonsteroidal anti-inflammatory drugs, Ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine, Treatment with local or systemic corticosteroids;, History of reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease;, History of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with 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, Treatment with monoamine oxidase (MAO) inhibitor therapy or discontinuation of the treatment less than 15 days before randomization;, Treatment with adrenergic augmenting psychotropic drugs/antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin);, Any change in any systemic medication that affects IOP within the last 30 days (e.g. clonidine, etc.);, History of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema, Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide);, 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, Narrow-angle/angle-closure glaucoma;, Corneal abnormalities that will preclude accurate IOP reading with an aplanation tonometer, Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment);, Intraocular surgery within the past 3 months;, Ocular laser surgery within the past 1 months;, Best-corrected visual acuity < 20 of 100 (Snellen), corresponding to worse than 0.7 logarithm of minimal angle of resolution (logMAR) score;, Cup/disk ratio >0.8;
研究者
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