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

November 1, 2016 updated by: Adenovir Pharma AB

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 14 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 14 days
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.
Time Frame: 14 days
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.
Time Frame: 14 days
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.
Time Frame: 28 days
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.
Time Frame: 14 days
Occurrence of second eye infection.
14 days
Assess the safety and tolerability of APD-209 Eye drops.
Time Frame: 14 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adenovir Pharma AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TFS Trial Form Support

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carl Gustaf Laurell, MD PhD, St Eriks Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012/ADE002
  • 2012-005694-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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