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

NCT ID: NCT01977443

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Viral Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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APD-209 Eye drops

APD-209 Eye drops

Group Type ACTIVE_COMPARATOR

APD-209 Eye drops

Intervention Type DRUG

APD-209 Placebo Eye drops

APD-209 Placebo Eye drops

Group Type PLACEBO_COMPARATOR

APD-209 Placebo Eye drops

Intervention Type DRUG

Interventions

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APD-209 Eye drops

Intervention Type DRUG

APD-209 Placebo Eye drops

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TFS Trial Form Support

INDUSTRY

Sponsor Role collaborator

Adenovir Pharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Gustaf Laurell, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St Eriks Eye Hospital

Locations

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Augenklinik Universitätzmedizin Charité

Berlin, , Germany

Site Status

Augenklinik Köln, Merheim

Cologne, , Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status

Universitäts-Augenklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitäts-klinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Augenklinik, Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Universitäts-Augenklinik

Würzburg, , Germany

Site Status

Katowice University Hospital

Katowice, , Poland

Site Status

P. Oleksy Centrum Medyczne Uno-Med

Tarnów, , Poland

Site Status

St Eriks Eye Hospital

Stockholm, , Sweden

Site Status

Countries

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Germany Poland Sweden

Other Identifiers

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2012-005694-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/ADE002

Identifier Type: -

Identifier Source: org_study_id