Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
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.
Drug: APD-209 Eye drops
Drug: APD-209 Placebo Eye drops
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Occurrence of second eye infection.
- Assess the safety and tolerability of APD-209 Eye drops. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01977443
|Contact: Björn Dellgren, M.Sc.||+46 (0)42 38 74 firstname.lastname@example.org|
|Contact: Anita Westin Tocaj, Ph.D. M.Sc.||+46 (0)46 280 18 email@example.com|
|Augenklinik Universitätzmedizin Charité||Recruiting|
|Berlin, Germany, 12200|
|Contact: Nicole Stübiger, Prof Dr|
|Düsseldorf, Germany, 40225|
|Contact: Gerd Geerling, Prof MD|
|Freiburg, Germany, 79106|
|Contact: Chris Böhringer, Prof Dr|
|Augenklinik Köln, Merheim||Recruiting|
|Köln, Germany, 51109|
|Contact: Stefan Christmann, Dr|
|Lübeck, Germany, 23538|
|Contact: Anne Brüggemann, Dr med|
|Augenklinik, Universitätsklinikum Tübingen||Recruiting|
|Tübingen, Germany, 72026|
|Contact: Christoph Deuter, Dr. med|
|Würzburg, Germany, 97080|
|Contact: Daniel Kampik, Dr med|
|St Eriks Eye Hospital||Recruiting|
|Contact: Carl Gustaf Laurell, MD PhD|
|Principal Investigator:||Carl Gustaf Laurell, MD PhD||St Eriks Eye Hospital|