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 study

Adenovir Pharma AB0 个研究点目标入组 130 人开始时间: 2013年5月21日最近更新: 2016年5月2日

适应症

试验速览

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•Men or women aged 18 to 65 years (inclusive) with onset of adenoviral EKC symptoms in at least one eye, as diagnosed by a positive Ad quick test (AdenoPlus), and with symptoms appearing within less than 48 hours at the time of giving informed consent will be included in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Known or suspected allergy to any ingredient of the IMP or placebo.
•2) Symptoms correlating with EKC since >48 hours.
•3) Diagnosis of other disease(s) than EKC in anterior chamber of the eye.
•4) Diagnosis of bacterial of fungal ocular infections.
•5) Use of antibiotics or corticosteroids by any route within 14 days prior to inclusion.
•6) Use of antiviral medications within 7 days prior to inclusion.
•7) Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
•8) Usage of any medication or herbal medicinal product for ocular administration at inclusion.
•9) Female subjects: currently pregnant or breast-feeding or intending to become pregnant during the study period.
•10) Known or suspected drug abuse.
•11) Usage of contact lenses during the study.
•12) Participation in any other interventional clinical study within 30 days prior to inclusion.
•13) Previous inclusion in this study.
•14) Living together with a person who is already included in this study.
•15) Any other reason that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.

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