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

Viral Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977443
• Other study ID #: 2012/ADE002
• Secondary ID: 2012-005694-31
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2013
• Last updated: November 1, 2016
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Adenovir Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Viral
• Keratoconjunctivitis
• Viral Conjunctivitis

Intervention

Drug:
• APD-209 Eye drops

• APD-209 Placebo Eye drops

Locations

Country	Name	City	State
Germany	Augenklinik Universitätzmedizin Charité	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitäts-Augenklinik Freiburg	Freiburg
Germany	Augenklinik Köln, Merheim	Köln
Germany	Universitäts-klinikum Schleswig-Holstein	Lübeck
Germany	Augenklinik, Universitätsklinikum Tübingen	Tübingen
Germany	Universitäts-Augenklinik	Würzburg
Poland	Katowice University Hospital	Katowice
Poland	P. Oleksy Centrum Medyczne Uno-Med	Tarnow
Sweden	St Eriks Eye Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Adenovir Pharma AB	TFS Trial Form Support

Countries where clinical trial is conducted

Germany,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assess the frequency of second eye infections.	Occurrence of second eye infection.	14 days	No
Secondary	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	Yes