Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Relationship between goblet cell density and the risk of conjunctivitis
研究概览
简要总结
Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .
排除标准
- •Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment
结局指标
主要结局
Relationship between goblet cell density and the risk of conjunctivitis
时间窗: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
Establish the relationship between goblet cell densitiy and the risk of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.
Relationship between goblet cell density and the incidence of conjunctivitis over time
时间窗: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
Establish the relationship between goblet cell densitiy and the incidence of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.
次要结局
- Optimal treatment of conjunctivitis(at the moment of the development of eye symptoms, 4 weeks after ocular treatment)
- Conjunctival changes during dupilumab treatment using Impression Cytology(baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment)
研究者
Dr M.S. de Bruin-Weller
Principle Investigator
UMC Utrecht