NCT07617532尚未招募3 期
A Randomized Clinical Trial to Evaluate the Safety and Efficacy of DNN.31.19.026 for the Treatment of Ocular Hypertension or Primary Open-Angle Glaucoma
Ache Laboratorios Farmaceuticos S.A.0 个研究点目标入组 336 人开始时间: 2026年6月1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
- 入组人数
- 336
研究概览
简要总结
This study aims to evaluate the safety and efficacy of DNN.31.19.026 compared with Cosopt® for the treatment of ocular hypertension or primary open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of either sex, aged ≥18 years;
- •Participants diagnosed with ocular hypertension or primary open-angle glaucoma according to the Clinical Protocol and Therapeutic Guidelines for Glaucoma;
- •Participants requiring ocular hypotensive treatment in one or both eyes, for whom the use of combination topical ocular hypotensive medications is appropriate for intraocular pressure (IOP) reduction.
排除标准
- •Participants diagnosed with primary open-angle glaucoma with no prior treatment history for the disease;
- •Participants with a cup-to-disc ratio >0.8 (horizontal or vertical);
- •Participants with any other clinically significant ocular disease that, in the investigator's opinion, may interfere with the evaluation of study efficacy and safety variables;
- •Participants with ocular infection or inflammation within 3 months prior to the screening/run-in visit;
- •Participants with a history of trabeculoplasty (within the last 6 months) or surgical procedures for IOP reduction;
- •Participants with a history of ocular surgery within 6 months prior to the screening/run-in visit;
- •Participants with any corneal abnormality that may affect IOP measurement;
- •Participants with respiratory or pulmonary disorders, such as asthma or chronic obstructive pulmonary disease (COPD);
- •Participants with the following cardiac conditions: sinus bradycardia, sinoatrial block, second- or third-degree atrioventricular block, overt heart failure, or cardiogenic shock;
- •Participants with uncontrolled systemic diseases, such as diabetes, hypertension, chronic hepatic or renal disorders, or any other medical condition that, in the investigator's opinion, may interfere with the investigational product or comparator.
研究者
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