NCT03723811已完成2 期
A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change from baseline of Fluorescein Corneal Staining(FCS) score
研究概览
简要总结
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet all criteria listed below at least in one eye.
- •Fluorescein corneal staining score ≥ 2
- •Schirmer test ≤ 10mm in 5 mins
- •Tear break-up time ≤ 10 secs
排除标准
- •Ocular disorder that may confound interpretation of study results.
- •Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.
- •History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.
- •Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.
- •Participation in other studies within 30 days of screening visit.
研究组 & 干预措施
1
Experimental
SJP002 BID
干预措施: SJP002 BID (Drug)
2
Experimental
SJP002 QID
干预措施: SJP002 QID (Drug)
Placebo 1
Placebo Comparator
SJP002 Placebo 1
干预措施: SJP002 Placebo 1 (Drug)
Placebo 2
Placebo Comparator
SJP002 Placebo 2
干预措施: SJP002 Placebo 2 (Drug)
结局指标
主要结局
Change from baseline of Fluorescein Corneal Staining(FCS) score
时间窗: 4 weeks
The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, \>E).
次要结局
- Change from baseline of Fluorescein Corneal Staining(FCS) score(2 weeks)
- Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score(2, 4 weeks)
- Change from baseline of Schirmer Test score(2, 4 weeks)
- Change from baseline of Tear Break-Up Time(TBUT)(2, 4 weeks)
- Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)(4 weeks)
- Numbers of used artificial tears during the study period(4 weeks)
研究者
研究点 (1)
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