The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- TBUT (Tear-Break-Up-Time)
研究概览
简要总结
This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. The study will consist on 3 visits: Visit 1 (day -3 from surgery), Visit 2 (day 0, surgery), and Visit 3 (day 7 from surgery). Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. At each visit all study procedures will be performed according to the clinical investigation plan requirements. Patients will be enrolled at Visit 1 and randomized with a 1:1 ratio to 2 groups:
GROUP A: patients receiving Visuprime eyedrop BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (QID) from day 0 (after surgery) to the end of the study.
GROUP B: patients receiving placebo eyedrop (the vehicle of Visuprime, i.e. isotonic buffered saline solution) BID from day -3 to week 1.
After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID + levofloxacin eyedrop QID from day 0 to the end of the study.
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
- None
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
- •At least 18 years old patients, male and female
- •Previous diagnosis of cataract requiring surgery
- •Wishing to participate in the study and able to sign the ICF
- •No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
排除标准
- •Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
- •Previous participation on this study for the fellow eye
- •Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
- •Coexisting corneal diseases
- •Past or active conjunctivitis - any type
- •Past ocular surface burns
- •Keratinization of the eyelid margin
- •Sjogren syndrome
- •History of corneal trauma
- •Pregnant and lactating women
- •Inability to self-administer study medications
- •Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
- •Participation in a clinical trial during the 3 months prior to the beginning of the study.
结局指标
主要结局
TBUT (Tear-Break-Up-Time)
时间窗: V3-V1 (ten days) , V2-V1(three days)
To evaluate the performance of the Visuprime, used in improving ocular surface homeostasis in patients receiving cataract surgery, the difference in the change of Tear Break-Up Time test will be analyzed between two treatment groups at V3 compared to V1 and at V2 compared to V1.
次要结局
- Ocular Surface Disease Index (OSDI)(V3-V1(ten days), V2-V1(three days))
- mNIBUT (mean NIBUT)(V3-V1(ten days), V2-V1(three days))
- Bacterial Load(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))
- Corneal staining(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))
- Instantaneous Non-Invasive Break-up time (iNIBUT)(V3-V1(ten days), V2-V1(three days))
- VAS (Visual Analogue Scale)(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))
- Tear meniscus height (TMH)(V3-V1 (ten days), V2-V1(three days))
- Conjunctival hyperemia(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))
- mean Non-Invasive Break-up time (mNIBUT)(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))
- 5-point Likert Scale(V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery))