NCT00941486终止2 期
A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
研究概览
简要总结
The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute 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
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.
- •Clinical suspicion of adenoviral etiology.
- •At least three (3) years of age.
- •Subjects or their guardians 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:
- •conjunctival injection/inflammation, and
- •conjunctival discharge/exudates.
排除标准
- •Conjunctivitis longer than 7 days after initial ocular symptoms.
- •Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
- •Patients taking ocular anti-inflammatory medications on a chronic basis.
- •Active herpes ocular infection.
- •Known or suspected pregnancy.
- •Known allergy to PVP-I.
- •Known allergy to dexamethasone.
- •Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").
研究组 & 干预措施
FST-100 Ophthalmic Suspension
Experimental
FST-100 (PVP-I 0.4% and dexamethasone 0.1%)
干预措施: FST-100 Ophthalmic Suspension (Drug)
Vehicle
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
时间窗: 1 year
次要结局
- Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.(1 year)
研究者
研究点 (10)
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