A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Sustained Clinical Cure
研究概览
简要总结
The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).
Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
详细描述
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3
- Visit 3: Day 6
- Visit 4: Day 11 End of Treatment (EOT)
- Visit 5: Day 18 Test-of-Cure (TOC)
- Visit 6: Day 42 Follow-up
Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
- •Bulbar conjunctival injection
- •Other inclusion criteria per protocol
排除标准
- •Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
- •A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
- •Other exclusion criteria per protocol
研究组 & 干预措施
NVC-422 Solution, 0.3%
Dosed for 10 days
干预措施: NVC-422 Solution, 0.3% (Drug)
NVC-422 Vehicle Solution
Dosed for 10 days
干预措施: NVC-422 Vehicle Solution (Drug)
结局指标
主要结局
Sustained Clinical Cure
时间窗: Day 18
次要结局
未报告次要终点