Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
|ClinicalTrials.gov Identifier: NCT01977443|
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : November 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Viral Conjunctivitis||Drug: APD-209 Eye drops Drug: APD-209 Placebo Eye drops||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||November 2013|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
Active Comparator: APD-209 Eye drops
APD-209 Eye drops
|Drug: APD-209 Eye drops|
Placebo Comparator: APD-209 Placebo Eye drops
APD-209 Placebo Eye drops
|Drug: APD-209 Placebo Eye drops|
- 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. [ Time Frame: 14 days ]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.
- Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ]The time point of viral eradication in tear liquid from EKC infected eyes, defined as the time Point when viral load=0 or below the lower limit of quantification (LLOQ).
- 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. [ Time Frame: 14 days ]Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.
- Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ]Presence and location of opacities at each time of assessment, as measured by slit lamp examination.
- Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 28 days ]Visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.
- Assess the frequency of second eye infections. [ Time Frame: 14 days ]Occurrence of second eye infection.
- Assess the safety and tolerability of APD-209 Eye drops. [ Time Frame: 14 days ]Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977443
|Augenklinik Universitätzmedizin Charité|
|Berlin, Germany, 12200|
|Düsseldorf, Germany, 40225|
|Freiburg, Germany, 79106|
|Augenklinik Köln, Merheim|
|Köln, Germany, 51109|
|Lübeck, Germany, 23538|
|Augenklinik, Universitätsklinikum Tübingen|
|Tübingen, Germany, 72026|
|Würzburg, Germany, 97080|
|Katowice University Hospital|
|Katowice, Poland, 40-514|
|P. Oleksy Centrum Medyczne Uno-Med|
|Tarnow, Poland, 33-100|
|St Eriks Eye Hospital|
|Principal Investigator:||Carl Gustaf Laurell, MD PhD||St Eriks Eye Hospital|