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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
47
Augenklinik Universitätzmedizin Charité
Berlin, Germany
Augenklinik Köln, Merheim
Cologne, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitäts-Augenklinik Freiburg
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.
Time frame: 14 days
Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.
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).
Time frame: 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.
Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.
Time frame: 14 days
Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.
Presence and location of opacities at each time of assessment, as measured by slit lamp examination.
Time frame: 14 days
Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.
Visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.
Time frame: 28 days
Assess the frequency of second eye infections.
Occurrence of second eye infection.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Freiburg im Breisgau, Germany
Universitäts-klinikum Schleswig-Holstein
Lübeck, Germany
Augenklinik, Universitätsklinikum Tübingen
Tübingen, Germany
Universitäts-Augenklinik
Würzburg, Germany
Katowice University Hospital
Katowice, Poland
P. Oleksy Centrum Medyczne Uno-Med
Tarnów, Poland
St Eriks Eye Hospital
Stockholm, Sweden
Time frame: 14 days
Assess the safety and tolerability of APD-209 Eye drops.
Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)
Time frame: 14 days