A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 96
- 主要终点
- Safety as Assessed by Dilated Fundus Examination
研究概览
简要总结
This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK). Subjects with bilateral NK may enroll in the study but only one eye will be selected as the study eye (worse eye) and be treated with test article.
- •Subjects with no clinical evidence of improvement in the PED or corneal ulcer within the 2 weeks prior to study enrollment despite the use of conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses [either silicone hydrogel or rigid gas permeable]) as determined by the investigator or referring physician's medical record.
- •Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye in the opinion of the investigator assessed with a cotton wisp.
- •Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in the study eye.
- •Subjects must have the ability and willingness to comply with study procedures.
排除标准
- •Any active ocular infection (bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in either eye in the opinion of the investigator. Infectious epithelial keratitis including herpetic keratitis (i.e., dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oral antibiotic at the time of screening are eligible but should continue the medication for the duration of the study.
- •Previous use of Oxervate in the study eye with last administration within the past 2 months.
- •Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study.
- •Use of any other topical treatments other than the study medication provided by the Sponsor and allowed by the study protocol can be administered to the study eye over the course of the study. The following are exceptions: a) Allowance for use of preservative-free antibiotic eye drops if prescribed by the investigator and b) Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular drop administered once-daily (QD) in glaucomatous eyes over the course of the study.
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
Vehicle Control Arm
One drop matching vehicle four times daily for 8 weeks in the study eye
干预措施: Vehicle Control (Biological)
CSB-001 Investigational Treatment Arm
One drop CSB-001 four times daily for 8 weeks 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 Dilated Fundus Examination
时间窗: Screening through Week 10
Change from baseline in observed anomalies of the peripheral retina, macula, choroid, optic nerve and vitreous (cup/disc ratio)
Safety as Assessed by Best-Corrected Distance Visual Acuity
时间窗: Screening through Week 10
Change from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart
Safety as Assessed by Adverse Event Reporting
时间窗: Screening through Week 10
Incidence of ocular and systemic adverse events
Safety as Assessed by Slit-lamp Biomicroscopy
时间窗: Screening through Week 10
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 Intraocular Pressure
时间窗: Screening through Week 10
Change in baseline in intraocular pressure using the Goldmann tonometry
Efficacy as Assessed by Complete Corneal Healing
时间窗: Week 8 through Week 10
Percentage of subjects achieving complete corneal healing in study eye as assessed by the Central Reading Center (CRC). Complete corneal healing was defined as absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 8 and the absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 10.
次要结局
- Efficacy as Assessed by Corneal Healing(Week 1 through Week 10)
- Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks(Weeks 4 and 8 through Week 10)
- Efficacy as Assessed by Decrease in Lesion Size(Week 1 through Week 10)
- Efficacy as Assessed by Time to Corneal Healing(Week 1 through Week 10)
- Efficacy as Assessed by Best Corrected Distance Visual Acuity(Week 1 through Weeks 4 and 8)
- Efficacy as Assessed by Corneal Healing at Week 4(Week 1 through Week 4)