NCT05733624已完成2 期
A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease
SCAI Therapeutics11 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2023年1月5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
- 116
- 试验地点
- 11
- 主要终点
- Tear volume
研究概览
简要总结
This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female who over 19 years old
- •Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
- •Those who meet below criteria at least one of two eyes;
- •Those who have over than score 2 in corneal staining test-Oxford grading
- •Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
- •TBUT(Tear film break-up time) test result should be under 10sec.
- •The corrected visual acuity is 0.2 or more.
排除标准
- •Those who have clinically significant eye disease not related to dry eye syndrome
- •Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
- •Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
- •Those who have medical history with intraocular surgery 12months before screening visit
- •Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
- •Those who have medicated cyclosporine eye-drops 6weeks before screening visit
- •Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
- •Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
- •Those who have received other investigational drugs/devices 30 days before screening visit
- •Those who are inappropriate for participating in this study according to investigator's judgement
研究组 & 干预措施
SCAI-001 0.01%
Experimental
Cyclosporine 0.01%
干预措施: SCAI-001 0.01% eyedrop (Drug)
SCAI-001 0.02%
Experimental
Cyclosporine 0.02%
干预措施: SCAI-001 0.02% eyedrop (Drug)
Restasis
Active Comparator
Cyclosporine 0.05%
干预措施: Restasis 0.05% eyedrop (Drug)
结局指标
主要结局
Tear volume
时间窗: Change from baseline at 12 weeks
Schirmer's test
次要结局
- Tear volume(Change from baseline at 4, 8 weeks)
- Total number of rescue medication used(12weeks)
- Corneal staining score with fluorescein(Change from baseline at 4, 8, 12 weeks)
- conjunctival staining score with Lissamine green(Change from baseline at 4, 8, 12 weeks)
- Tear film break-up time(Change from baseline at 4, 8, 12 weeks)
- Standard patient evaluation of eye dryness questionnaire(Change from baseline at 4, 8, 12 weeks)
- Ocular surface disease index(Change from baseline at 4, 8, 12 weeks)
研究者
研究点 (11)
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