Amniotic Membrane Treatment for Hyposecretory Dry Eye
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Lisamina green conjunctival staining
研究概览
简要总结
The goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (AMEED) in reducing signs and symptoms of hyposecretory dry eye
Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th.
Researchers will compare against autologous serum eye drops effects
详细描述
This was a randomized, active-controlled, parallel-group trial. The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation.
During de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ASED) or AMEED, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •dry eye related symptoms
- •Fluorescein Corneal Staining score of 4 or more
- •Lisamina Green Conjunctival score of 4 or more
- •a no-anesthesia Schirmer test value at 5' of 10 mm or less
排除标准
- •glaucoma treatment
- •surgical procedures within 3 months of the baseline evaluation
- •precense of punctal plug
- •patients that were human immunodeficiency virus positive
结局指标
主要结局
Lisamina green conjunctival staining
时间窗: 1 month
changes in the lisamina green conjunctival staining (LGCS) score to demonstrate ocular surface damage
次要结局
- Schirmer's test(1 month)
- Fluorescein Corneal staining(1 month)
- TBUT(1 month)
- OSDI(1 month)
研究者
Emiliano Facundo Ross
Medical doctor
Hospital Nacional Profesor Alejandro Posadas