A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of SJP-0035 0.001% for the Treatment of Patients With Dry Eye Disease (DELTA-1 Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 23
- 主要终点
- Corneal fluorescein staining
研究概览
简要总结
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo
详细描述
There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 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)
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
- •Signed informed consent form (ICF).
- •Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
- •Has blurred vision caused by DED in both eyes.
- •Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
- •Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.
排除标准
- •Has any corneal stromal or endothelial abnormalities in either eye.
- •Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
- •Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
- •Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
- •Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
- •Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration of the study.
- •Has previously received SJP-0035 (study drug) in either eye.
- •Currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at Screening through the duration of the study.
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
SJP-0035 0.001% (ophthalmic solution)
干预措施: SJP-0035 0.001% (Drug)
Placebo (ophthalmic solution)
干预措施: Placebo (Drug)
结局指标
主要结局
Corneal fluorescein staining
时间窗: Week 5
Number of patients showing complete clearing of corneal fluorescein staining, scored on the Baylor grading system.
次要结局
- Blurred vision(Week 5)