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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
47
3 countries
10
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2013
Actual (reported)September 2016
Actual (reported)September 2016
Actual (reported)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.
Viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment.
14 days
Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.
14 days
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.
14 days
Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.
14 days
Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.
28 days
Assess the frequency of second eye infections.
14 days
APD-209 Eye drops
APD-209 Placebo Eye drops
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Augenklinik Universitätzmedizin Charité
Berlin, 12200, Germany
Augenklinik Köln, Merheim
Cologne, 51109, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitäts-Augenklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Universitäts-klinikum Schleswig-Holstein
Lübeck, 23538, Germany
Augenklinik, Universitätsklinikum Tübingen
Tübingen, 72026, Germany
Universitäts-Augenklinik
Würzburg, 97080, Germany
Carl Gustaf Laurell, MD PhD
St Eriks Eye Hospital
47 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2013
First Posted
November 6, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Katowice University Hospital
Katowice, 40-514, Poland
P. Oleksy Centrum Medyczne Uno-Med
Tarnów, 33-100, Poland
St Eriks Eye Hospital
Stockholm, Sweden
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
November 2, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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