The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Change in glaucomatous damage
研究概览
简要总结
Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.
Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.
All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).
The secondary objective is to assess the tolerability and safety of OMK1 eye drops.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
- •Patients with -2 < MD < -15 dB, progression of MD at least -0,5 dB/y for 2 years.
- •Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
- •Patients over the age of 18 years
排除标准
- •Patients with contraindications to citicoline
- •Patients with IOP higher than 18 mmHg
- •Patients with other forms of glaucoma
- •Patients treated with other neuroprotective therapies
- •Women who are pregnant and/or breastfeeding
- •Pediatric or adolescent patients aged under 18 years
研究组 & 干预措施
Citicoline eye drops (OMK1)
45 patients will be treated with active treatment (OMK1)
干预措施: Citicoline eye drops (OMK1) (Device)
hypromellose based ocular lubricant
45 patients will be treated with placebo (lubricant eye drops)
干预措施: Placebo Comparator: hypromellose based ocular lubricant (Other)
结局指标
主要结局
Change in glaucomatous damage
时间窗: Baseline and Visit at 36 months
The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure.
次要结局
- progression of glaucoma in the SD OCT examination(Baseline and Visit at 36 months)
研究者
Luca Rossetti
Director Clinical Ophthalmologist P.O. San Paolo Milan
University of Milan