Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKC MedDRA version: 14.1 Level: LLT Classification code 10014975 Term: Epidemic keratoconjunctivitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: ADE CTP-12-001
Product Code: APD-209
Pharmaceutical Form: Eye drops, suspension
CAS Number: 1333495-72-9
Current Sponsor code: APD-209
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Adenovir Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women aged 18 to 65 years (inclusive) with onset of adenoviral EKC symptoms in at least one eye, as diagnosed by a positive Ad quick test (AdenoPlus), and with symptoms appearing within less than 48 hours at the time of giving informed consent will be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to any ingredient of the IMP or placebo. 2) Symptoms correlating with EKC since >48 hours. 3) Diagnosis of other disease(s) than EKC in anterior chamber of the eye. 4) Diagnosis of bacterial of fungal ocular infections. 5) Use of antibiotics or corticosteroids by any route within 14 days prior to inclusion. 6) Use of antiviral medications within 7 days prior to inclusion. 7) Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes. 8) Usage of any medication or herbal medicinal product for ocular administration at inclusion. 9) Female subjects: currently pregnant or breast-feeding or intending to become pregnant during the study period. 10) Known or suspected drug abuse. 11) Usage of contact lenses during the study. 12) Participation in any other interventional clinical study within 30 days prior to inclusion. 13) Previous inclusion in this study. 14) Living together with a person who is already included in this study. 15) Any other reason that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • Assess the time to viral eradication in EKC infected eyes following treatment with APD 209 Eye drops compared to placebo. • 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. • Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD 209 Eye drops compared to placebo. • Assess the visual acuity following treatment with APD 209 Eye drops compared to placebo. • Assess the frequency of second eye infections. • Assess the safety and tolerability of APD 209 Eye drops.;Timepoint(s) of evaluation of this end point: Following LSLV;Main Objective: To assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops given 8 times daily for 14 days compared to placebo.;Primary end point(s): Virological success as measured by a reduction of 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Virological success as measured by a reduction of viral load in tear liquid from EKC infected eyes, as measured by the AUC at 0-14 days from start of treatment. • To determine 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). • To assess resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness. • To assess resolution of ocular symptoms at each time of assessment, as measured by subjective (Patient Worksheet) assessment of irritation, foreign body sensation, tearing, pain and blurred vision. • To assess presence and location of opacities at each time of assessment, as measured by slit lamp examination. • To assess visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart. • To assess occurrence of second eye infection. Safety of APD-209 by recording of • Adverse events (AEs) (nature and incidence) • Physical examination • Vital signs • Laboratory safety assessments (haematology, clinical chemistry and urinalysis) ;Timepoint(s) of evaluation of this end point: Following LSLV | — |
Countries
Germany, Poland, Sweden
Contacts
Public ContactCEO
Adenovir Pharma AB
Outcome results
None listed