Multicenter, controlled, randomized, observer-blinded clinical trial to evaluate the efficacy and safety of insulin eye drops (1 IU/ml) in the treatment of persistent corneal epithelial defect.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation.
研究概览
简要总结
To evaluate the efficacy of using insulin eye drops, comparing it with standard medical treatment (autologous serum eye drops), in the treatment of persistent epithelial defect of neurotrophic origin or secondary to chronic ocular surface diseases.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Diagnosis of persistent corneal epithelial defect
- •Signature of informed consent
- •Negative serology for HIV, HCV, HBV, HLTV and syphilis.
排除标准
- •Pregnancy or lactation
- •Extreme stromal thinning (residual corneal thickness less than 60% of total corneal thickness).
- •Severe limbal corneal ischaemia (grade IV or higher on the Dua scale, 6 hours or more of limbal ischaemia).
结局指标
主要结局
Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation.
Closure or non-closure of the persistent epithelial defect, expressed as percentage of patients with complete re-epithelialisation.
Closure rate (area of initial defect / days to epithelialisation, in mm2/day).
Closure rate (area of initial defect / days to epithelialisation, in mm2/day).
Time to complete closure (in days) (closure in first two weeks of treatment: complete success; closure in first month of treatment: partial success).
Time to complete closure (in days) (closure in first two weeks of treatment: complete success; closure in first month of treatment: partial success).
次要结局
- Percentage of patients with insufficient response.
- Percentage of patients with treatment failure.
- Description of other variables and relationship with response: age, sex, comorbidities, aetiology of the epithelial defect, time since diagnosis, previous treatment, previous surgeries, visual acuity.
- Closure or not of the PED and rate of closure in those patients who receive both treatments due to insufficient effect of one of them in isolation.
研究者
Pedro Arriola Villalobos
Scientific
Hospital Clinico San Carlos