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

NCT01977443 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Viral Conjunctivitis

Interventions

DRUG

APD-209 Eye drops

DRUG

APD-209 Placebo Eye drops

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Adenovir Pharma AB

    lead INDUSTRY

Principal Investigators

  • Carl Gustaf Laurell, MD PhD · St Eriks Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Germany
  • Poland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977443 on ClinicalTrials.gov