Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

Adenovir Pharma

Status and phase

Completed

Phase 2

Conditions

Viral Conjunctivitis

Treatments

Drug: APD-209 Placebo Eye drops

Drug: APD-209 Eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT01977443

2012/ADE002

2012-005694-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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