Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI) Score
研究概览
简要总结
The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome
详细描述
To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Man/woman ≥ 18 years old, able to freely give consent to participate in the study
- •At least 1 of the following tests altered:
- •Ocular Surface Disease Index (OSDI) Test symptoms > 32
- •BUT ≤5 seconds
- •Oxford staining ≥ 3
- •Schirmer Test without anesthesia ≤ 5 mm
排除标准
- •Sensitivity or known intolerance to any of the products used in the study
- •Contraindication of venipuncture
- •Story of ocular infections within the 6 previous months to study inclusion
- •Any active ocular pathology other than Dry Eye Syndrome
- •Use of contact lenses in the 3 previous months to study inclusion
- •No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
- •Participation in another clinical trial in the last 30 days before study inclusion
研究组 & 干预措施
Autologous Serum 20%
Treatment with Autologous Serum 20% for 2 months
干预措施: Autologous Serum 20% (Drug)
Autologous Serum 50%
Treatment with Autologous Serum 50% for 2 months
干预措施: Autologous Serum 50% (Drug)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI) Score
时间窗: 1 month
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
次要结局
- Change in Ocular Surface Disease Index (OSDI) Score(1 week, 2 months)
- Change in Schirmer I(1 week, 1 month, 2 months)
- Change in Tear Break Up Time (TBUT)(1 week, 1 month, 2 months)
- Change in Oxford Staining score(1 week, 1 month, 2 months)