Clinical trial NCT01977443: Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Viral Conjunctivitis
Lead sponsor: Adenovir Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: TFS Trial Form Support
First posted: 2013-11-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary objective is to assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops compared to placebo.
timeFrame: 14 days
Secondary outcomes:
measure: Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.
timeFrame: 14 days
measure: Evaluate the effect of APD-209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo.
timeFrame: 14 days
measure: Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.
timeFrame: 14 days
measure: Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.
timeFrame: 28 days
measure: Assess the frequency of second eye infections.
timeFrame: 14 days
measure: Assess the safety and tolerability of APD-209 Eye drops.
timeFrame: 14 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Augenklinik Universitätzmedizin Charité
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Freiburg
country: Germany
facility: Universitäts-Augenklinik Freiburg
city: Köln
country: Germany
facility: Augenklinik Köln, Merheim
city: Lübeck
country: Germany
facility: Universitäts-klinikum Schleswig-Holstein
city: Tübingen
country: Germany
facility: Augenklinik, Universitätsklinikum Tübingen
city: Würzburg
country: Germany
facility: Universitäts-Augenklinik
city: Katowice
country: Poland
facility: Katowice University Hospital
city: Tarnow
country: Poland
facility: P. Oleksy Centrum Medyczne Uno-Med
city: Stockholm
country: Sweden
facility: St Eriks Eye Hospital
Study officials:
affiliation: St Eriks Eye Hospital
name: Carl Gustaf Laurell, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: