jRCTs031240193招募中不适用
ROCK inhibitor (ripasudil)-Alpha2 adrenoceptor agonist (brimonidine) fixed-dose combination ophthalmic solution v.s. Beta-blocker (timolol)-Carbonic anhydrase inhibitor (dorzolamide) fixed-dose combination ophthalmic solution comparison study on intraocular pressure lowering efficacy (ROCK-ABC study)
未提供0 个研究点目标入组 114 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who understand the contents of the informed consent documet of this study, and give written consent to pariticipate in this study by their free will.
- •Male or female who aged 18 years or older at giving their consent.
- •Patients who are diagnosed with primary open-angle glaucoma (in broad definition) or ocular hypertension.
- •Patients who received prostanoid receptor agonist (FP receptor agonist, EP2 receptor agonist) alone for 4 cibsecutive weeks or longer prior to giving their consent.
- •Patients who require additional treatment due to ocular pressure of at least one eye or 15mmHg or higher at giving their consent
排除标准
- •Patients with history or complication of bronchial asthma, bronchospasm, or severe chronic obstructive pulmonary disease
- •Patients with unstable heart failure, sinus bradycardia, atrioventricular block (degree II or III), cardiogenic shock, right heart failure due to pulmonary hypertension, or congestive heart failure
- •Patients with hypersensitivity to any component of study agent in this study
- •Patients with severe renal impairment
- •Patients with diabetic ketoacidosis and metabolic acidosis
- •Patients with inadequately controlled diabetes mellitus
- •Patients with hepatic impairment
- •Patients with cerebrovascular disorders or orthostatic hypotension
- •Patients with cardiovascular disease
- •Patients with history or complication of chronic or recurrent severe ocular inflammatory disease (scleritis, uveitis, herpes keratitis) in any eye
- •Patients with history of ocular trauma within 6 months prior to giving their consent in the study eye
- •Patients with complication of ocular infection or endophthalmitis in any eye
- •Patients with history or complication of clinically problematic or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, or retinal detachment) in any eye
- •Patients who received endophthalmic surgery within 6 months prior to giving their consent in the study eye
- •Patients who received ophthalmic laser surgery within 3 months prior to giving their consent in the study eye
- •Patients whose study eye has difficulty measuring intraocular pressure with a plain tonometer
- •Patients with best corrected visual acuity (fractional visual acuity) of 0.2 or less in the study eye
- •Patients with a corner angle grade of 2 or less according to the Shaffer classification in the study eye
- •Patients with significant visual field impairment that the responsible investigator or subinvestigator determines to be inappropriate to participate in the study
- •Patients who cannot safely discontinue the use of ophthalmic or systemic corticosteroids until completion of treatment with the study agent or control agent
- •Wommen who are pregnant, breastfeeding, or planning to be pregnant
- •Patients who have participated or currently participating in another clinical study within 30 days prior to giving their consent
- •Patients who are judged by the responsible investigator or subinvestigator to be inappropriate to participate in this study due to history of serioud disease or current health condition, etc.
结局指标
主要结局
-
Change in ocular pressure of 2 hours after the eydrop from baseline to week 4 or 8
次要结局
- Change in ocular pressure(baseline to week 4 or 8)
- Frequency of adverse event or disease-or-the-like
- Change in blood pressure(baseline to week 4 or 8)
- Change in pulse rate(baseline to week 4 or 8)
- Questionnaire about the usability of the eydrop
研究者
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