NCT01189474已完成4 期
Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 58
研究概览
简要总结
Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .
Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.
This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.
Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent.
- •Male or female up to 4 years old.
- •Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month.
- •Without any active pathology requiring a change in ocular treatments within the last month before inclusion.
- •Best corrected far visual acuity (VA) > 1/10
排除标准
- 未提供
研究者
研究点 (58)
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