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

This is an interventional treatment trial for Viral Conjunctivitis Read More

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