Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)

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

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 Overview

• Status: Completed
• Conditions: Viral Conjunctivitis
• Intervention / Treatment: Drug: APD-209 Eye drops; Drug: APD-209 Placebo Eye drops

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Augenklinik Universitätzmedizin Charité
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Freiburg, Germany, 79106
    • Universitäts-Augenklinik Freiburg
  • Köln, Germany, 51109
    • Augenklinik Köln, Merheim
  • Lübeck, Germany, 23538
    • Universitäts-klinikum Schleswig-Holstein
  • Tübingen, Germany, 72026
    • Augenklinik, Universitätsklinikum Tübingen
  • Würzburg, Germany, 97080
    • Universitäts-Augenklinik
• Poland
  • Katowice, Poland, 40-514
    • Katowice University Hospital
  • Tarnow, Poland, 33-100
    • P. Oleksy Centrum Medyczne Uno-Med
• Sweden
  • Stockholm, Sweden
    • St Eriks Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The patients have to meet all of the following criteria to be eligible to enter the study:

• Willing and able to provide informed consent.
• Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as clinically diagnosed and with symptoms appearing within less 7 days at the time of giving informed consent.
• Using adequate contraceptive measures

Exclusion Criteria:

• Known or suspected allergy to any ingredient of the IMP or placebo.
• Symptoms correlating with EKC since more than 7 days.
• Diagnosis of other significant disease(s) than EKC in the eye.
• Diagnosis of bacterial or fungal ocular infections.
• Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited during the study.
• Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
• Use of antiviral medications within 7 days prior to inclusion.
• Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
• Usage of any medication or herbal medicinal product for ocular administration at inclusion.
• Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
• Known or suspected drug abuse.
• Usage of contact lenses during the study.
• Participation in any other interventional clinical study within 30 days prior to inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: APD-209 Eye drops	Drug: APD-209 Eye drops
Placebo Comparator: APD-209 Placebo Eye drops	Drug: APD-209 Placebo Eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	28 days
Assess the frequency of second eye infections.	Occurrence of second eye infection.	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)	14 days

Collaborators and Investigators

• Sponsor: Adenovir Pharma AB
• Collaborators: TFS Trial Form Support
• Investigators: Principal Investigator: Carl Gustaf Laurell, MD PhD, St Eriks Eye Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Infections; Eye Infections, Viral; Conjunctivitis; Keratoconjunctivitis; Conjunctivitis, Viral; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 2012/ADE002; 2012-005694-31 (EudraCT Number)