A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- tear-film breakup time
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to participate in this clinical study, and signed informed consent
- •age from 18 to 70 years old,both genders are permitted
- •diagnosed as the Sjögren syndrome
- •have the symptoms and signs of dry eye disease as below:
- •have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than
- •the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
- •the score of corneal fluorescein staining greater than 3.
排除标准
- 未提供
结局指标
主要结局
tear-film breakup time
时间窗: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
stain the cornea with the fluorescein; close the eye; open the eye and keep the eye open,count the seconds until the first black spot appears.
Schirmer test I without anesthesia
时间窗: the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment
put the Schirmer test strip into the lower conjunctival sac; close the eye for 5 minutes; read the score of the test strip
corneal fluorescein staining
时间窗: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Fluorescein staining scores were measured on 0-3 point scale, in each quarter of corneal zone: 0(No staining), 1(some staining), 2(Staining in more than a half of the area), 3(Staining in the whole area).
次要结局
未报告次要终点
研究者
Lan Gong
Professor
Santen Pharmaceutical(China) Co.,LTD