NCT01977443

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

October 31, 2013

Last Update Submit

November 1, 2016

Conditions

Viral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Assess the time to viral eradication in EKC infected eyes following treatment with APD-209 Eye drops compared to placebo.

    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.

    14 days

  • Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD-209 Eye drops compared to placebo.

    14 days

  • Assess the visual acuity following treatment with APD-209 Eye drops compared to placebo.

    28 days

  • Assess the frequency of second eye infections.

    14 days

  • +1 more secondary outcomes

Study Arms (2)

APD-209 Eye drops

ACTIVE COMPARATOR

APD-209 Eye drops

Drug: APD-209 Eye drops

APD-209 Placebo Eye drops

PLACEBO COMPARATOR

APD-209 Placebo Eye drops

Drug: APD-209 Placebo Eye drops

Interventions

APD-209 Eye dropsDRUG
APD-209 Eye drops
APD-209 Placebo Eye dropsDRUG
APD-209 Placebo Eye drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Augenklinik Universitätzmedizin Charité

Berlin, 12200, Germany

Location

Augenklinik Köln, Merheim

Cologne, 51109, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitäts-Augenklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitäts-klinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Augenklinik, Universitätsklinikum Tübingen

Tübingen, 72026, Germany

Location

Universitäts-Augenklinik

Würzburg, 97080, Germany

Location

Katowice University Hospital

Katowice, 40-514, Poland

Location

P. Oleksy Centrum Medyczne Uno-Med

Tarnów, 33-100, Poland

Location

St Eriks Eye Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Conjunctivitis, Viral

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Study Officials

  • Carl Gustaf Laurell, MD PhD

    St Eriks Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 6, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

SE(1)DE(7)PL(2)