Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
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|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|
|Actual Primary Completion Date :||September 2016|
|Actual 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|