Post-approval Study to Assess the Effectiveness of LAMELLEYE vs Comparator for the Treatment of Dry Eye Symptoms in Patients With Primary Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 主要终点
- Patient reported symptoms
研究概览
简要总结
Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.
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.
The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion, each Participant must meet each of the following:
- •Male or female aged ≥ 18 years and ≤ 79 years at date of consent
- •Primary Sjögren's Syndrome diagnosed by a rheumatologist
- •Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
- •Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
- •Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.
排除标准
- •Participants are excluded from the study if any of the following criteria are met:
- •Females who are pregnant, planning pregnancy or breastfeeding
- •Active ocular infection or current corneal ulceration
- •Ocular surgery within 6 months of study start date
- •Current contact lens wear
- •Any prior and/or current topical ophthalmic treatments 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 prior to enrolment
- •Participants with known allergies to ingredients in any of the study treatments, or fluorescein
- •Participants who are judged inappropriate for inclusion in the study by the CI or PI.
结局指标
主要结局
Patient reported symptoms
时间窗: 28 days (analysed for each treatment period)
Ocular Surface Disease Index (OSDI): 12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning and Symptom Assessment in Dry Eye (SANDE): Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation
Patient reported quality of life
时间窗: 28 days (analysed for each treatment period)
Impact of Dry Eye Disease on Everyday Life (IDEEL - copyright Novartis Pharma AG): The use of this questionnaire (Treatment Satisfaction module only) will provide assessment of the impact of study treatment on patient outcomes in this study.
次要结局
- Osmolarity(28 days (analysed for each treatment period))
- Inflammatory markers(28 days (analysed for each treatment period))
- Non-invasive tear break-up time (NITBUT)(28 days (analysed for each treatment period))
- Interferometry(28 days (analysed for each treatment period))
- Evaporimetry(28 days (analysed for each treatment period))
- Corneal and Conjunctival Staining(28 days (analysed for each treatment period))