Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
Information source: Adenovir Pharma AB
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Viral Conjunctivitis
Intervention: APD-209 Eye drops (Drug); APD-209 Placebo Eye drops (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Adenovir Pharma AB Official(s) and/or principal investigator(s): Carl Gustaf Laurell, MD PhD, Principal Investigator, Affiliation: St Eriks Eye Hospital
Overall contact: Björn Dellgren, M.Sc., Phone: +46 (0)42 38 74 28, Email: bjorn.dellgren@adenovir.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.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. Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo. Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo. Assess the frequency of second eye infections. Assess the safety and tolerability of APD-209 Eye drops.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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 to 65 years (inclusive) with onset of adenoviral EKC symptoms in
at least one eye, as clinically diagnosed and with symptoms appearing within less
than 72 hours 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 48 hours.
- 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.
- 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
Locations and Contacts
Björn Dellgren, M.Sc., Phone: +46 (0)42 38 74 28, Email: bjorn.dellgren@adenovir.com
Augenklinik Universitätzmedizin Charité, Berlin 12200, Germany; Recruiting Nicole Stübiger, Prof Dr
Universitätsklinikum Düsseldorf, Düsseldorf 40225, Germany; Recruiting Gerd Geerling, Prof MD
Universitäts-Augenklinik Freiburg, Freiburg 79106, Germany; Recruiting Chris Böhringer, Prof Dr
Augenklinik Köln, Merheim, Köln 51109, Germany; Recruiting Stefan Christmann, Dr
Universitäts-klinikum Schleswig-Holstein, Lübeck 23538, Germany; Recruiting Anne Brüggemann, Dr med
Augenklinik, Universitätsklinikum Tübingen, Tübingen 72026, Germany; Recruiting Christoph Deuter, Dr. med
Universitäts-Augenklinik, Würzburg 97080, Germany; Recruiting Daniel Kampik, Dr med
St Eriks Eye Hospital, Stockholm, Sweden; Recruiting Carl Gustaf Laurell, MD PhD
Additional Information
Starting date: November 2013
Last updated: April 30, 2015
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