NCT01977443已完成2 期
Evaluation of the Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Acute Phase Adenoviral-Induced Epidemic Keratoconjunctivitis (EKC). A Randomised, Double-Masked, Placebo-Controlled, Multi-Centre Proof-of-Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo.
研究概览
简要总结
A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC. The aims of the study are to investigate the therapeutic efficacy of APD-209 Eye drops as measured by adenoviral load, time to viral eradication, clinical resolution of EKC (objective and subjective assessments), presence of opacities, visual acuity and frequency of second eye infections, and to assess the safety and tolerability of APD-209 Eye drops in EKC infected eyes.
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
- Triple (Participant, Care Provider, 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
- •The patients have to meet all of the following criteria to be eligible to enter the study:
- •Willing and able to provide informed consent.
- •Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as clinically diagnosed and with symptoms appearing within less 7 days at the time of giving informed consent.
- •Using adequate contraceptive measures
排除标准
- •Known or suspected allergy to any ingredient of the IMP or placebo.
- •Symptoms correlating with EKC since more than 7 days.
- •Diagnosis of other significant disease(s) than EKC in the eye.
- •Diagnosis of bacterial or fungal ocular infections.
- •Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited during the study.
- •Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
- •Use of antiviral medications within 7 days prior to inclusion.
- •Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
- •Usage of any medication or herbal medicinal product for ocular administration at inclusion.
- •Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
- •Known or suspected drug abuse.
- •Usage of contact lenses during the study.
- •Participation in any other interventional clinical study within 30 days prior to inclusion
研究组 & 干预措施
APD-209 Eye drops
Active Comparator
APD-209 Eye drops
干预措施: APD-209 Eye drops (Drug)
APD-209 Placebo Eye drops
Placebo Comparator
APD-209 Placebo Eye drops
干预措施: APD-209 Placebo Eye drops (Drug)
结局指标
主要结局
The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo.
时间窗: 14 days
Viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment.
次要结局
- Assess the frequency of second eye infections.(14 days)
- Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.(14 days)
- Evaluate the effect of APD-209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo.(14 days)
- Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.(14 days)
- Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.(28 days)
- Assess the safety and tolerability of APD-209 Eye drops.(14 days)
研究者
研究点 (10)
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Study comparing the efficacy of Eye drops containing the substance APD-209 and placebo for the treatment the a viral eye infection called Adenoviral-induced Epidemic Keratoconjunctivitis (EKC).Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKCMedDRA version: 18.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862EUCTR2012-005694-31-DEAdenovir Pharma AB130
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Evaluation of the Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Acute Phase Adenoviral-Induced Epidemic Keratoconjunctivitis (EKC). A Randomised, Double-Masked, Placebo-Controlled, Multi-Centre Proof-of-Concept Study - APD-209 Eye drops phase IIa studyAcute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKCMedDRA version: 18.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862EUCTR2012-005694-31-PLAdenovir Pharma AB47
进行中（未招募）
不适用
Study comparing the efficacy of Eye drops containing the substance APD-209 and placebo for the treatment the a viral eye infection called Adenoviral-induced Epidemic Keratoconjunctivitis (EKC).Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKCMedDRA version: 14.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862EUCTR2012-005694-31-SEAdenovir Pharma AB130