A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 26
- 主要终点
- Symptom Assessment in Dry Eye (SANDE) Questionnaire
研究概览
简要总结
SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.
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
All investigational product (SDP-4 concentrations and vehicle) will be provided in single-use doses (SUDs) contained in foil pouches.
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 DED in both eyes for ≥ 6 months prior to Visit 1/Screening.
- •Total score ≥ 40 on the SANDE questionnaire.
- •Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
- •Anesthetized Schirmer's test tear volume ≥ 4 mm and <10 mm in both eyes.
排除标准
- •Ocular surface corneal disease, other than DED.
- •Lid margin disorder other than meibomian gland dysfunction (MGD).
- •Any previous reconstructive or cosmetic eyelid surgery that may affect the normal function of the lids
- •Any previous invasive glaucoma and/or corneal surgery
- •Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
- •Cataract extraction within 90 days prior to Visit 1/Screening.
- •Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
- •Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
研究组 & 干预措施
SDP-4 Ophthalmic Solution (1.0%)
Mid concentration of SDP-4
干预措施: SDP-4 Ophthalmic Solution (1.0%) (Drug)
Vehicle
Vehicle
干预措施: Vehicle (Drug)
SDP-4 Ophthalmic Solution (3.0%)
High concentration of SDP-4
干预措施: SDP-4 Ophthalmic Solution (3.0%) (Drug)
SDP-4 Ophthalmic Solution (0.1%)
Low concentration of SDP-4
干预措施: SDP-4 Ophthalmic Solution (0.1%) (Drug)
结局指标
主要结局
Symptom Assessment in Dry Eye (SANDE) Questionnaire
时间窗: 84 days
Mean change from baseline in total SANDE score at Visit 7/Day 84 The SANDE questionnaire contained two questions regarding the frequency and severity of DED symptoms, with a total score being the square root of the frequency score times the square root of the severity score (range 0 100). A higher score indicates more severe DED symptoms.
次要结局
- Anesthetized Schirmer's Test(84 days)
- Conjunctival Hyperemia(84 days)
- Tear Breakup Time(84 days)
- Corneal Fluoroscein Staining(84 days)