A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
研究概览
简要总结
This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).
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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit
- •Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
- •Have corneal erosive disease (e.g., confluent staining [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
- •Have a history of glaucoma or intraocular pressure (IOP) >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
- •Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
研究组 & 干预措施
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%
干预措施: SY-201 Ophthalmic Solution 1.0% (Drug)
SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%
干预措施: SY-201 Ophthalmic Solution 0.5% (Drug)
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%
干预措施: SY-201 Ophthalmic Solution 2.0% (Drug)
SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle
干预措施: SY-201 Ophthalmic Solution Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
时间窗: 60 days
Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
时间窗: 60 days
Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.
次要结局
- Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60(60 days)
- Change From Baseline in Symptom Severity Score (Subscale) at Day 60(60 days)