Evaluation of the Effect of Citicoline (Cebrolux 800 mg) and Docosahexaenoic Acid (DHA) Compound (BrudyPio 1.5 g) on the Visual Function of Patients With Glaucoma With a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Effect on Visual Field Index (VFI)
研究概览
简要总结
Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:
- •Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT.
- •Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.
- •There must be at least 3 reliable visual fields prior to the start of the study.
- •Patients between 50 and 75 years old, homogeneously distributed among the groups.
- •Glaucoma with functional and structural damage.
- •Medium grade, Mean Deviation (MD) between -4 and -20 dB.
- •In at least one eye.
排除标准
- •Treatment with some other vitamin or nutraceutical preparation.
- •Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
- •Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
- •Allergic to fish protein.
- •Eye surgery in the 3 months before or during the study.
研究组 & 干预措施
Citicoline and Docosahexaenoic Acid (DHA)
Cebrolux 800 and Brudypio 1.5g (see above).
干预措施: Citicoline and Docosahexaenoic Acid (DHA) (Dietary Supplement)
Docosahexaenoic Acid (DHA)
Brudypio 1.5g is a food supplement based on Omega-3 fatty acid in the form of triglycerides (DHA 70% [350 mg], EPA 8.5%, DPA 6%) that also contains vitamins (A, B1, B2, B3, B6, B9, B12, C, E), carotenoids ( lutein, zeaxanthin, lycopene), glutathione, coenzyme Q10 and minerals (Zn, Se, Cu, Mn).
干预措施: Docosahexaenoic Acid (DHA) (Dietary Supplement)
Citicoline
Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.
干预措施: Citicoline (Dietary Supplement)
Vitamin C
Vitamin C.
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Effect on Visual Field Index (VFI)
时间窗: From Baseline to Month 3.
Evaluation of changes on the VFI (%) with study treatment.
Effect on Mean Defect (MD)
时间窗: From Baseline to Month 3.
Evaluation of changes on the MD (decibels) with study treatment.
次要结局
- Evaluation of tolerance(From Month 1 to Month 3)
- Evaluation of the changes produced in the intraocular pressure (IOP)(From Baseline to Month 3.)