NCT05677685已完成不适用
Multicentre Randomized Double-blind Trial of VISUPRIME® Eye Drops to be Evaluated in Preventing the Conjunctival Bacterial Load in Patients Undergoing to Anti-VEGF Injection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- CFU (Colony Forming Units)
研究概览
简要总结
The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection.
详细描述
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.
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
- •Adult patients (age ≥ 18)
- •Naïve and pre-treated patients scheduled for IVI
- •Diagnosis of one of the following:
- •Proliferative diabetic retinopathy
- •Diabetic macular oedema
- •Macular oedema secondary to retinal vein occlusion
- •The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local Ethics Committee (EC).
排除标准
- •Use of systemic antibiotics, corticosteroids within 3 months
- •Use of topical antibiotics and or corticosteroids within 15 days from study enrolment
- •Use of topical Artificial Tears within 15 days from the enrolment
- •Use of topical antiseptic agents within 1 month from study enrolments
- •Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
- •Ongoing ocular or systemic inflammatory or infectious processes
- •Known hypersensitivity to the constituents of the study product
- •Diagnosis of Open-Angle Glaucoma
- •Acute and Chronic Conjunctival Disease
- •Any intraocular surgery within 6 months from study enrolment, excluded IVI
- •Severe and Moderate Dry Eye
- •Pregnancy or breast-feeding
- •Participation in other clinical studies
- •Patients with cognitive impairment and unable to manage home-assigned treatment.
研究组 & 干预措施
Investigational Device
Active Comparator
干预措施: VISUPRIME (Device)
Placebo
Placebo Comparator
干预措施: Placebo (Device)
结局指标
主要结局
CFU (Colony Forming Units)
时间窗: three days
Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1.
次要结局
- SANDE Symptom Assessment iN Dry Eye(three days)
- Adverse Events(three days)
- Antibiotic sensitivity(three days)
研究者
研究点 (6)
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