RBR-3crsfj尚未招募3 期
Phase III, multicenter, double-blind, randomized, controlled, 12-week, parallel-group, superiority trial to compare the efficacy and safety of the triple fixed combination of dorzolamide hydrochloride (2%) + brimonidine tartrate (0.2%) + timolol maleate (0.5%) versus COMBIGAN® (double fixed combination of 0.2% brimonidine tartrate + 0.5% timolol maleate) in reducing intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension
aboratório Daudt Oliveira Ltda.0 个研究点开始时间: 2020年1月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 —（—）
入选标准
- •Men or women aged 18 years-old or over; having a diagnosis of primary open-angle glaucoma or ocular hypertension; being able to sign the ICF approved by IRB and to execute and understand all study procedures and instructions; having intraocular pressure greater than or equal to 21 and less than or equal to 30 mmHg in, at least, one eye; having an optical disc excavation of 0,8 or less
排除标准
- •Presenting blindness in one eye; having visual acuity worse than or equal to 20/40 in either eye without justified cause; presenting a history of any concomitant active-stage eye disease, except those specified in
- •inclusion criteria; for participants taking medication to treat primary open-angle glaucoma or ocular hypertension may only participate in the study if they discontinue the drug for a period of up to 7 (± 2) to 30 (± 2) days, according to the therapeutic class of the medication used; making use of topical corticosteroids ophtalmic or topical within
- •14 days from the screening visit. It is prohibited the use of systemic corticosteroids and psychotropic medicines with adrenergic potential (eg desipramine, amitriptyline) within 1 month of the screening visit or any other medication which, regardless of the route of administration, interfere with the study results and offer a risk to the participant's safety, at the investigator's discretion, used within 48 hours prior to the screening visit or until residual effects may be present; having an allergy to sulfa drugs; having hypersensitivity to the active ingredients and excipients of the study medications; wearing contact lenses 7 days before the screening visit (pre-treatment) and throughout the study; current history of bronchial asthma or chronic obstructive pulmonary disease (COPD), sinus bradycardia, 2nd or 3rd degree heart block, heart failure, cardiogenic shock; current or previous history of severe renal or hepatic impairment,
- •current history of diabetic retinopathy or any other clinical condition that, at the investigator's discretion, contraindicates participation in the study or interferes with the study outcome; participants of childbearing age who do not agree to use a
- •adequate form of contraception; pregnant, nursing women who plan to become pregnant, or who have a positive pregnancy test on their blood test; having a history of cataract surgery with or without intraocular lens (IOL) implantation (pseudoaphakia or aphakia) within 3 months or less prior to the screening visit; having a recent history of alcohol and/or drug abuse or excessive alcohol consumption; presenting corneal abnormalities that interfere with an accurate reading of intraocular pressure by a Goldmann applanation tonometer; being part of a clinical study within the last 12 months unless, at the discretion of the investigator, it represents a benefit to the participant
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