Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- NicOx
- 试验地点
- 1
- 主要终点
- Viral eradication time NCX 4240 versus Placebo
研究概览
简要总结
This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in decreasing the number of days where adenoviral conjunctivis is detected in the eye and in reducing the duration and/or the severity of the signs and symptoms of adenoviral conjunctivis
详细描述
A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing carrageenan eye drops (NCX 4240) versus placebo up to 21 days.
Total expected number of patients: 148
Randomization: patients will be randomized 1:1 between:
- Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8 times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days until Day 21 or
- Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye 8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day 21.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test
- •Conjunctivis signs and symptoms in at least one eye AND positive adenoplus test in at least one eye whatever signs/symptoms and positive adenoplus test are from the same eye or not
排除标准
- •Negative results with adenoplus test in both eyes
- •a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
研究组 & 干预措施
Eye drops containing Iota-Carrageenan
Eye drops 3.2mg/ml
干预措施: Iota-Carrageenan (Drug)
Ocular Lubricant Eye Drops
Carmellose 0.5% sterile solution
干预措施: Carmellose (Drug)
结局指标
主要结局
Viral eradication time NCX 4240 versus Placebo
时间窗: 21 days
Comparison in time to viral eradication in NCX-4240 and the placebo groups (when virus load is 0 or BLD - below the limit of detection) from the tears as measured by Polymerase Chain Reaction (PCR) at each visit.
次要结局
- Quantitative PCR(21 days)
- Impact on daily activities(21 days)
- bulbar conjuntival infection(21 days)
- Other signs to be assessed(21 days)
- loco-regional lymphadenopathies(21 days)
- Ocular symptoms assessed by patients(21 days)
- Disease impact on daily activities(21 days)
- Global patient discomfort(21 days)
- Patient discomfort(21 days)
- Adenoplus test results(21 days)
- Investigator's assessment of Membranes and pseudomembranes development(21 days)
- Investigator's assessment of Subepithelial Corneal Infiltrates development(21 days)
- Assessment of Incidence and severity of fellow eye signs and symptoms(21 days)
- BCVA(21 days)
- Global assessment of patient's satisfaction(21 days)
- Adverse events(21 days)