NCT04038034Unknown不适用
Clinical Evaluation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) 100 mg BID Oral Administration in Patients Affected by Primary Open Angle Glaucoma (POAG): a Randomized, Double Blind Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Pattern Electroretinogram Amplitude (PERG P50-N95 A)
研究概览
简要总结
This is a randomized, double blind study with competitive enrolment, aimed to enroll a total of 70 patients with a diagnosis of primary open angle glaucoma (POAG).
Patients, after signing the Informed Consent, will enter into a 1- week screening phase during which the baseline tests will be conducted.
Subjects will be randomized in a 1:1 ratio to the following groups:
- group A of 35 patients treated with pressure lowering drugs and placebo;
- group B of 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pattern Electroretinogram Amplitude (PERG P50-N95 A)
时间窗: between the baseline visit (V0) and the last study visit after 12 months of treatment (V3)
To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups.
次要结局
- Optical Coherence Tomography(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
- Visual Evoked Potentials Implicit Times (VEP P100 IT)(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
- Pattern Electroretinogram Amplitude (PERG P50-N95 A)(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
- Visual Evoked Potentials Amplitude (VEP N75-P100 A)(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
- Visual field(from baseline to each study visit (V1, V2, V3))
- Contrast sensitivity(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
- Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT)(between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3))
研究者
研究点 (3)
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