Autologous Serum Efficacy Study in Patients With Severe Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.
研究概览
简要总结
The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.
详细描述
Severe dry eye remains an important and frequent eye disease, that reflects in a severe impairment of the patient´s life quality. Up to date there is no ideal therapy for this condition. Few studies have reported some kind of improvement in different parameters related to dry eye with the use of autologous serum, but no one has considered the patient´s symptoms with a systematic and validated evaluation method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Severe Dry Eye, as defined by a OSDI score > or = 40
- •Tear Break Up Time (TBUT) < 5 seconds
- •Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.
排除标准
- •No dry eye associated ocular disease
- •Unable to comply protocol
- •Severe anemia
- •Previous use of autologous serum
- •Concomitant use of other topical ocular drug
- •Hypersensibility to any proposed interventions
研究组 & 干预措施
Autologous serum -Systane
Crossover arm starting with autologous serum for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane)
干预措施: Autologous serum - Systane (Drug)
Systane- Autologous serum
Crossover arm starting with artificial tears (Systane) for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.
干预措施: Systane - Autologous serum (Drug)
结局指标
主要结局
To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.
时间窗: 5 weeks
次要结局
- To compare variations in objective eye measurements, such as Tear Break Up Time and corneal-conjunctival staining according to the Oxford Score, in patients treated with autologous serum and conventional artificial tears.(5 weeks)