A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on Day 5
研究概览
简要总结
The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.
详细描述
This is a Phase II single-center, double-masked, placebo controlled, randomized study of SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will be assessed at day 1, day 3, and day 5 for efficacy and safety.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Conjunctivitis (as defined below) within 72 hours of initial ocular symptoms.
- •At least 18 years of age.
- •Subjects capable of understanding the purpose and risks of the study, and able to give informed consent.
- •Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis- 1) bulbar conjunctival injection and 2) conjunctival discharge/exudates.
- •A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to grade conjunctival discharge/exudates.
- •All patients will require a rating of 1(mild) or greater for conjunctival discharge/exudates.
- •Patients will require a rating of 1 (mild) for bulbar conjunctival injection.
排除标准
- •Conjunctivitis greater than 72 hours after initial ocular symptoms
- •Corneal ulcer, endophthalmitis, or any other confounding infection of the eye
- •Patients taking topical anti-inflammatory medications on a chronic basis
- •Known steroid glaucoma responders
- •Active herpes ocular infection
- •Pregnant women
- •Known allergy to chlorhexidine
研究组 & 干预措施
Placebo
Vehicle minus active components
干预措施: Placebo (Drug)
Treatment
Active treatment with SCH-1
干预措施: SCH-1 (Drug)
结局指标
主要结局
Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on Day 5
时间窗: Day 5
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 3 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SCH1 and placebo reporting groups.
Complete Clinical Resolution
时间窗: Day 5
Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome).
次要结局
未报告次要终点