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).

• Conditions: Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKC; MedDRA version: 14.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005694-31-SE
• Lead Sponsor: Adenovir Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-21
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified