A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Safety as Assessed by Slit-lamp Biomicroscopy
研究概览
简要总结
This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
- •Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
- •Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
- •Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
- •Subjects must have the ability and willingness to comply with study procedures.
排除标准
- •Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
- •Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
- •No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
- •Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
- •Ocular surgery planned during the study treatment period.
- •Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
CSB-001 QID
One drop CSB-001 four times daily for 14 days in the study eye
干预措施: CSB-001 Ophthalmic Solution 0.1% (Biological)
CSB-001 TID
One drop CSB-001 three times daily for 14 days in the study eye
干预措施: CSB-001 Ophthalmic Solution 0.1% (Biological)
结局指标
主要结局
Safety as Assessed by Slit-lamp Biomicroscopy
时间窗: Screening through Day 56
Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15
Safety as Assessed by Adverse Event Reporting
时间窗: Day 1 through Day 56
Incidence of ocular and systemic adverse events
Safety as Assessed by Best-Corrected Distance Visual Acuity
时间窗: Screening through Day 56
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
次要结局
- Efficacy as Assessed by Contrast Sensitivity(Screening through Day 56)
- Efficacy as Assessed by Area of Corneal Scar(Screening through Day 56)
- Efficacy as Assessed by Maximum Depth of Cornea Scar(Screening through Day 56)
- Efficacy as Assessed by Volume of Scar(Screening through Day 56)
- Efficacy as Assessed by Density of Scar(Screening through Day 56)
- Efficacy as Assessed by Distance Visual Acuity(Screening through Day 56)