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

Phase 1

• Conditions: Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKC; MedDRA version: 18.1Level: LLTClassification code 10014975Term: Epidemic keratoconjunctivitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Eye Diseases [C11]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-27
• Study Completion: 2016-04-12
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as diagnosed according to current clinical practice, and with symptoms appearing within less than 7 days 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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1) Known or suspected allergy to any ingredient of the IMP or placebo.
2) Symptoms correlating with EKC since more than 7 days.
3) Diagnosis of other significant disease(s) than EKC in the eye.
4) Diagnosis of bacterial or fungal ocular infections, as assessed by the Investigator.
5) 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.
6) Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
7) Use of antiviral medications within 7 days prior to inclusion.
8) Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes, assessed by the Investigator as being relevant for the study.
9) Usage of any medication or herbal medicinal product for ocular administration at inclusion.
10) Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
11) Known or suspected drug abuse.
12) Usage of contact lenses during the study.
13) Participation in any other interventional clinical study within 30 days prior to inclusion.
14) Previous inclusion in this study.
15) Living together with a person who is already included in this study.
16) 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