NCT00821561撤回2 期
A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Nexagon® in Subjects With Persistent Corneal Epithelial Defects (PED) From Chemical Burn Injuries.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 90
- 主要终点
- The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with Persistent Epithelial Defects (PED) originally caused by chemical burns.
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
- Double
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
- •Male and female subjects aged 18 years and over.
- •Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
- •Subjects who are willing and able to give written informed consent to take part in the study.
- •At the Day -7 visit subjects must have a corneal epithelial defect that has persisted for between 7 days and 14 days, which has a minimum diameter of 2 mm along the greatest axis, and which has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
- •The original defect to the cornea must have been caused by either alkaline or acidic agents.
排除标准
- •Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
- •Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period
- •Decrease or increase in the PED by more than 30% during the screening period.
- •Have an active lid or ocular infectious process of any sort
- •Subjects with corneal perforation or impending corneal perforation
- •The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
- •Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
- •Subjects with bilateral PED, if the smaller PED has a longest diameter of > 2 mm.
- •Female subjects who are pregnant or breastfeeding. F
- •Subjects who have a history of AIDS or HIV.
- •Subjects with any other condition which, in the Investigator's opinion, would exclude the subject from participating.
- •Treatment with systemic corticosteroids (equivalent to > 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0, or likely to receive one of these therapies during study participation
- •Subjects who have participated in a clinical trial within 30 days prior to Day
- •Diabetics with an HbA1c greater than 6.5%.
- •Diabetics who are currently prescribed more than one oral medication for their diabetes.
- •Subjects who have more than one distinct PED in the study eye.
结局指标
主要结局
The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.
次要结局
未报告次要终点
研究者
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