Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by (Responsible Party):
Adenovir Pharma AB
ClinicalTrials.gov Identifier:
NCT01977443
First received: October 31, 2013
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Viral Conjunctivitis
Drug: APD-209 Eye drops
Drug: APD-209 Placebo Eye drops
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Adenovir Pharma AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    Resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.

  • Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Presence and location of opacities at each time of assessment, as measured by slit lamp examination.

  • Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.

  • Assess the frequency of second eye infections. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Occurrence of second eye infection.

  • Assess the safety and tolerability of APD-209 Eye drops. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Safety variables: adverse events (AEs) (nature and incidence), Physical examination, vital signs, laboratory safety assessments (haematology, clinical chemistry and urinalysis)


Enrollment: 47
Study Start Date: November 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: APD-209 Eye drops
APD-209 Eye drops
Drug: APD-209 Eye drops
Placebo Comparator: APD-209 Placebo Eye drops
APD-209 Placebo Eye drops
Drug: APD-209 Placebo Eye drops

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977443

Locations
Germany
Augenklinik Universitätzmedizin Charité
Berlin, Germany, 12200
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Universitäts-Augenklinik Freiburg
Freiburg, Germany, 79106
Augenklinik Köln, Merheim
Köln, Germany, 51109
Universitäts-klinikum Schleswig-Holstein
Lübeck, Germany, 23538
Augenklinik, Universitätsklinikum Tübingen
Tübingen, Germany, 72026
Universitäts-Augenklinik
Würzburg, Germany, 97080
Poland
Katowice University Hospital
Katowice, Poland, 40-514
P. Oleksy Centrum Medyczne Uno-Med
Tarnow, Poland, 33-100
Sweden
St Eriks Eye Hospital
Stockholm, Sweden
Sponsors and Collaborators
Adenovir Pharma AB
TFS Trial Form Support
Investigators
Principal Investigator: Carl Gustaf Laurell, MD PhD St Eriks Eye Hospital
  More Information

Responsible Party: Adenovir Pharma AB
ClinicalTrials.gov Identifier: NCT01977443     History of Changes
Other Study ID Numbers: 2012/ADE002  2012-005694-31 
Study First Received: October 31, 2013
Last Updated: November 1, 2016
Health Authority: Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on December 09, 2016