A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study of SJP-0035 Ophthalmic Solution Compared With Placebo to Assess Safety and Efficacy of SJP-0035 Ophthalmic Solution for Corneal Epithelial Wound Healing in Patients With Moderate to Severe Corneal Epithelial Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- Clearing of corneal fluorescein staining at week 4
研究概览
简要总结
The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in promoting corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
详细描述
There is currently no product approved for corneal epithelial wound healing. A Phase 1 Study SJP-0035/1-01 was conducted in healthy volunteers to investigate the safety, tolerability, and pharmacokinetic profile of SJP-0035 ophthalmic solution and to determine the appropriate dose to be evaluated in patients with moderate to severe corneal epithelial disorders.
This Phase 2a study is being conducted to evaluate the safety and efficacy of SJP-0035 ophthalmic solution in patients to promote corneal epithelial wound healing in conditions associated with corneal epithelial disorders.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 75 years, inclusive.
- •Has moderate to severe superficial punctate keratitis (SPK) and/or corneal erosion in 1 or both eyes.
- •Has symptoms caused by corneal epithelial disorders.
- •Has not obtained improvement from previous treatment for the SPK or corneal erosion within the last 30 days.
- •Is a female of childbearing potential with a negative pregnancy test result at Screening and baseline and agrees to use effective contraception throughout the study or is a postmenopausal woman with a negative pregnancy test result at Screening and baseline.
排除标准
- •Has any corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, or chemical burns or any trauma to the cornea.
- •Any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures.
- •Had previous ocular/refractive surgery (including laser surgery) within the last 6 months.
- •Has used any ocular medication (except mydriatics, stain, and topical anesthesia used for study assessments) within 14 days prior to the first dose of study drug, or who are anticipated to require such medications during the study. Artificial tears may be used up to 72 hours prior to the first dose.
- •Is unable to discontinue Restasis. A 28-day washout period prior to the first dose of study drug is required.
- •Is a contact lens wearer and cannot discontinue use for the duration of the study.
- •Alcohol or drug abuse within the past 6 months.
- •Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus test at Screening.
研究组 & 干预措施
SJP-0035 Ophthalmic Solution
Patients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
干预措施: SJP-0035 Ophthalmic Solution (Drug)
Vehicle of SJP-0035 Ophthalmic Solution
Patients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks.
干预措施: Vehicle of SJP-0035 Ophthalmic Solution (Drug)
结局指标
主要结局
Clearing of corneal fluorescein staining at week 4
时间窗: measured at Week 4
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety.(baseline up to week 18)
- Changes of subjective symptoms: blurred vision, photophobia and eye irritation(screening up to week 18)
- Changes of subjective signs: tear stability, conjunctival epithelia, and surface curvature of cornea(screening up to week 18)