Post-approval Study to Assess Lamelleye vs Comparator for the Treatment of Dry Eye Disease in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Non-invasive tear break-up time (outcome used to power study)
研究概览
简要总结
Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.
详细描述
The study is a 2-way crossover design comprising 2 treatments: the CE-marked Lamelleye dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.
This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Participant has provided written informed consent.
- •Male or female Participants ≥ 18 and ≤ 79 years of age.
- •Participant has dry eye disease as diagnosed from positive responses to Non-invasive tear break-up time (NITBUT) (≤10 seconds); Schirmer test (≤10mm in 5 minutes); and patient symptoms (>2 symptoms using the McMonnies Dry Eye Questionnaire)
- •Participant must understand and be able, willing and likely to fully comply with study procedures and restrictions.
排除标准
- •Active ocular infection
- •Ocular surgery within 6 months of study start date
- •Current contact lens wear
- •Any ophthalmologic drops within 1 week prior to enrolment that in the opinion of the CI or PI may interfere with the study outcomes.
- •Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial visit.
- •Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit
- •Known hypersensitivity to any of the agents used in testing such as allergies to egg or soya based products.
- •Females who are or wish to become pregnant
研究组 & 干预措施
Treatment A, followed by Treatment B
Treatment group that will receive Treatment A for 14 days, followed by Treatment B for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.
干预措施: Lamelleye Dry Eye Drops (Device)
Treatment A, followed by Treatment B
Treatment group that will receive Treatment A for 14 days, followed by Treatment B for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.
干预措施: Optive Plus (Device)
Treatment B, followed by Treatment A
Treatment group that will receive Treatment B for 14 days, followed by Treatment A for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.
干预措施: Lamelleye Dry Eye Drops (Device)
Treatment B, followed by Treatment A
Treatment group that will receive Treatment B for 14 days, followed by Treatment A for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.
干预措施: Optive Plus (Device)
结局指标
主要结局
Non-invasive tear break-up time (outcome used to power study)
时间窗: 14 days (analysed for each Treatment period)
Measure of time taken from blink to breakup of tear film
次要结局
- Interferometry(14 days (analysed for each Treatment period))
- Ocular Surface Disease Index (OSDI)(14 days (analysed for each Treatment period))
- Symptom Assessment in Dry Eye (SANDE)(14 days (analysed for each Treatment period))
- Evaporimetry(14 days (analysed for each Treatment period))
- Osmolarity(14 days (analysed for each Treatment period))
- Corneal and Conjunctival Staining(14 days (analysed for each Treatment period))