Comparing the Effects of THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) With the Use of Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Tear film break-up time
研究概览
简要总结
An open label, randomized controlled study in a Norwegian population with meibomian gland dysfunction. Patients will be randomized to one of two groups: THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) or Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK). All patients will receive Hylo-comod (URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany).
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
- •Meibomian Gland Dysfunction
- •Eligible for heat treatment
- •Ocular Surface Disease Index (OSDI) >12
- •Quality or expressibility score ≤20 years old: >1 or >20 years old: ≥1
- •Non-invasive tear film break-up time (NITBUT) <10 s in at least one eye
- •Schirmer-1 test >5 mm after 5 min
排除标准
- •Glaucoma,
- •Ocular allergy
- •Autoimmune disease
- •Contact lens-wear during study
- •Current punctal plugging
- •Pregnant/lactating
- •Candidate for topical anti-inflammatory
- •Cicatricial meibomian gland dysfunction
研究组 & 干预措施
Blephasteam
Heat delivery device, to be used according to guidelines from manufacturer.
干预措施: Blephasteam (Device)
Blephasteam
Heat delivery device, to be used according to guidelines from manufacturer.
干预措施: Hylo-comod (Drug)
THERA°PEARL Eye Mask
Heat delivery device, to be used according to guidelines from manufacturer.
干预措施: THERA°PEARL Eye Mask (Device)
THERA°PEARL Eye Mask
Heat delivery device, to be used according to guidelines from manufacturer.
干预措施: Hylo-comod (Drug)
结局指标
主要结局
Tear film break-up time
时间窗: Change from baseline at three and six months
Fluorescein applied to tear film, time measured until tear film breaks up after blink. Range of scale from 1 second and higher, where higher values are considered preferable for the patients. Values under 10 seconds are indicative for dry eye disease.
次要结局
- McMonnies Questionnaire(Change from baseline at three and six months)
- Ocular Surface Disease Index(Change from baseline at three and six months)
- Ocular surface staining Ocular surface staining(Change from baseline at three and six months)
- Schirmer's test(Change from baseline at three and six months)
- Meibum Quality(Change from baseline at three and six months)
- Tear cytokine levels(Change from baseline at three and six months)
- Meibum Expressibility(Change from baseline at three and six months)
- Tear osmolarity(Change from baseline at three and six months)
研究者
Jonatan Olafsson
Medical Student
Oslo University Hospital