Randomized, Double-blind, Controlled Trial Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Patients Affected by Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
This is a randomized, parallel arm, multicenter, double-blind trial.
Patients with POAG will be randomized 1:1 ratio to receive:
- Prostaglandin analogue (PGA) monotherapy + CoQun® (Arm A)
- Prostaglandin analogue (PGA) monotherapy + Vehicle (Arm B)
详细描述
CoQun® 10 ml is a medical device marked by the European Community as class IIb. This device has a system of dispensation that permits it to be preservative free (OSD - Ophthalmic Squeeze Dispenser). Investigators and patients will be masked to the study treatment. In order to mask the treatment, identical kit boxes, identical packaging (bottles and labels) will be used for vehicle and active product. The bottles will be dispensed sealed to the patient.
One or two drops of the solution (CoQun® or Vehicle) will be instilled in the conjunctival sac of both eyes, twice daily from 8 to 10 AM and from 8 to 10 PM. Hypotensive therapy should be administered in the evening one hour after the CoQun® or Vehicle administration.
At baseline, ocular hypotensive treatment, as per inclusion criteria has to be a PGA monotherapy. During the follow-up, in case the IOP exceeds 28 mmHg, any additional hypotensive therapy will be allowed to obtain IOP control.
Dose modifications/reductions of CoQun® /Vehicle are not permitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind study
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of POAG (monolateral or bilateral) with an IOP ranging from 17 to 21 mm Hg (at the last performed visit and confirmed at the baseline study visit) on treatment with a topical prostaglandin analogue (PGA) monotherapy.
- •VF examination at randomization: VF Mean Defect (MD) at baseline within -4 decibel (dB) and -10dB and VF Pattern Standard Deviation (PSD) within 4 dB and 10dB (stage 2-3 per the Enhanced Glaucoma Staging System 2 (GSS) determined by Humphrey Field Analyzer II-i, program 30-2 SITA standard.
- •In order to determine patient's reliability to perform VF examination: before baseline VF, at least two reliable VF examinations during the last year had to be performed. Visual fields are considered reliable if false-positive responses are fewer than 15% and a clear blind spot could be seen in the VF printouts, threshold value <10 dB.
- •Age >40 years
- •Provision of informed consent prior to any study specific procedures
排除标准
- •Secondary glaucoma (exofoliative glaucoma, pigmentary glaucoma, neovascular glaucoma).
- •Abnormalities of the anterior segment of the eye that could affect IOP assessment.
- •Cornea abnormalities with entities that could affect IOP evaluation.
- •Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage).
- •BCVA) < 0.5 Snellen decimal fraction
- •Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty).
- •Pregnancy or breast-feeding.
结局指标
主要结局
Time to Progression (TTP)
时间窗: Randomization till VF progression, up to 36 months
Time to Progression (TTP) defined as the time between baseline visit and the visit with the first evidence of progression in either eye is detected. When progression is detected, the progression should be confirmed at the two subsequent and consecutive Visual Field (VF) examinations.VF examinations will be assessed by an independent reading centre.
次要结局
- Velocity of Visual Field (VF) loss(Randomization till VF progression, up to 36 months)
- Retinal Nerve Fiber Layer (RNFL) thickness(Randomization till VF progression, up to 36 months)
- Intraocular pressure (IOP)(Randomization till VF progression, up to 36 months)
- Best Correct Visual Acuity (BCVA)(Randomization till VF progression, up to 36 months)