CTRI/2019/08/020943Other2 期
A Phase 2, randomized, prospective, double-masked, vehicle controlled study to assess the efficacy and safety of Nexagon�® (NEXAGON) applied topically in subjects with corneal persistent epithelial defects (PED) resulting from severe ocular chemical and/or thermal injuries. - EXPEDE
OcuNexus Therapeutics Inc0 个研究点目标入组 33 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female of any age.
- •2.The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
- •3.The PED is non-responsive to current standard of care for at least 14 days from injury.
- •4.The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- •5.Providing written informed consent and ability to comply with the visit and dosing schedule.
排除标准
- •1.Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
- •2.Have active ocular infection.
- •3.Subjects with corneal perforation or impending corneal perforation.
- •4.Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
- •5.Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- •6.Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
- •7.Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
研究者
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