NCT04556838已完成2 期
A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease
VivaVision Biotech, Inc1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2020年12月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Inferior Corneal Fluorescein Staining
研究概览
简要总结
This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.
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
Double-masked
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
- •Provide written informed consent prior to any study-related procedures .
- •Are 18 years of age or older.
- •Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
- •Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
- •Have a history of dry eye disease in both eyes
- •Are currently using artificial tears and have been using within 30 days of the screening visit.
- •Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (0-100 point VAS)
- •Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2:
- •Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
- •Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.
排除标准
- •Have a known hypersensitivity or contraindication to the IP or components of IP.
- •Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
- •Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
研究组 & 干预措施
VVN001, 1%
Experimental
VVN001, 1% ophthalmic solution
干预措施: VVN001 Ophthalmic Solution 1% (Drug)
VVN001, 5%
Experimental
VVN001, 5% ophthalmic solution
干预措施: VVN001 Ophthalmic Solution 5% (Drug)
Vehicle
Placebo Comparator
VVN001 Ophthalmic Solution Placebo
干预措施: Vehicle (Drug)
结局指标
主要结局
Inferior Corneal Fluorescein Staining
时间窗: Day 84
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
次要结局
- Total Corneal Fluorescein Staining(Day 84)
- Regional Corneal Fluorescein Staining(Day 84)
- Eye Dryness(Day 84)
研究者
研究点 (1)
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