A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Response status
研究概览
简要总结
The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED.
详细描述
Approximately 90 participants diagnosed with persistent corneal epithelial defect (PCED) will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy. After an initial cohort of at least 2 participants to evaluate the safety of the high strength product, participants in the second cohort will be randomized to treatment with either the product or vehicle (placebo) for 8 weeks. The percentage of healing will be compared between groups treated with product and vehicle. Total length of study participation will be approximately 34 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Cohort 1: open-label Cohort 2: masked to participant, Investigator, site staff, outcomes assessor, etc
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
- •Have PCED for at least 7 days prior due to an underlying condition such as diabetic keratopathy, herpetic eye disease, severe dry eye disease, limbal stem cell deficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery, medical trauma, chemical burn, etc.
- •PCED measurements meet study criteria.
排除标准
- •Any active ocular infection or any active infectious disease that could impact the PCED.
- •Severe corneal burns in the Study Eye.
- •Severe limbal stem cell deficiency in either eye.
- •The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.
- •Severe blepharitis or severe meibomian gland disease.
- •Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.
- •Evidence of corneal ulceration.
- •Anticipated need for punctal occlusion.
- •Use of Oxervate in the Study Eye within past 30 days.
- •History of any surgical procedure for treatment of the study PCED.
- •History of any other ocular surgery in the Study Eye within 90 days prior to screening.
- •Not willing to suspend use of contact lens in the Study Eye.
- •Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.
- •Expected use of systemic doxycycline.
- •Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.
- •History of current drug or alcohol abuse or addiction.
- •Use of another investigational agent within 30 days.
- •Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.
研究组 & 干预措施
Cohort 1, Arm 1
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
干预措施: KPI-012 (Drug)
Cohort 2, Arm 1
KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days
干预措施: KPI-012 (Drug)
Cohort 2, Arm 2
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
干预措施: KPI-012 (Drug)
Cohort 2, Arm 3
KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days
干预措施: KPI-012 Vehicle (Drug)
结局指标
主要结局
Response status
时间窗: Day 56
Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.
次要结局
未报告次要终点