A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 217
- 主要终点
- Microbiological Success
研究概览
简要总结
The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.
详细描述
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3 (±1)
- Visit 3: Day 5 (+1) Test of Cure/Exit
IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.
Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.
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)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 year of age and older
- •Bulbar conjunctival injection
- •Conjunctival discharge/exudate
- •Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
- •Other inclusion criteria per protocol
排除标准
- •Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
- •Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
- •Other exclusion criteria per protocol
研究组 & 干预措施
Auriclosene Solution 0.3%
Dosed QID for 4 Days
干预措施: Auriclosene Solution 0.3% (Drug)
Auriclosene Vehicle
Dosed QID for 4 days
干预措施: Auriclosene Vehicle (Drug)
结局指标
主要结局
Microbiological Success
时间窗: 5 days
Eradication of all pre-therapy isolates
次要结局
- Clinical Cure(5 days)