A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Adenoviral Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 156
- 试验地点
- 31
- 主要终点
- Percentage of Participants With Clinical Resolution on Day 6
研究概览
简要总结
The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SHP640
Participants instructed to instill 1 drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
干预措施: SHP640 (Drug)
Placebo
Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Resolution on Day 6
时间窗: Day 6
Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.
次要结局
- Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)(Day 3, 8 and 12/ET)
- Percentage of Participants With Adenoviral Eradication on Day 6(Day 6)
- Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8(Day 6 and 8)
- Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)(Day 3, 8 and 12/ET)
- Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)(Day 3, 6, 8 and 12/ET)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From start of study drug administration up to Day 13)