Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- break-up time (BUT)
研究概览
简要总结
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.
详细描述
This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.
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
- 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
- •Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT >7
- •Normal to mild DED according to OSDI chart
- •Diagnosis of Cataract requiring surgery
- •Wishing to participate in the study and able to sign the ICF
- •Shirmer test > 15 mm /5'
- •No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
排除标准
- •Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
- •Patients with diagnosis of Glaucoma
- •Functional and anatomic eyelid abnormalities,
- •Complicated cataract,
- •Suture affixing during surgery,
- •Use of artificial tears in the month preceding the study visit
- •Coexisting corneal diseases
- •Autoimmune diseases
- •Past or active cicatricial conjunctivitis
- •Past ocular surface burns
- •Keratinization of the eyelid margin
- •Sjogren syndrome
- •History of corneal trauma
- •Pregnant and lactating women
- •Younger than 18 years old patients
- •Inability to self-administer study medications
- •Known 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
研究组 & 干预措施
patients receiving MAF-1217
patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery.
干预措施: MAF-1217 (Device)
patients receiving just standard antibiotic therapy
patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery).
结局指标
主要结局
break-up time (BUT)
时间窗: 1 month
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)
次要结局
- Schirmer test I(1 month)
- OSDI score(1 month)
- osmolarity(1 month)