NCT02054273

Brief Summary

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

13 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

January 17, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

January 17, 2014

Last Update Submit

January 10, 2017

Conditions

Viral Conjunctivitis

Keywords

Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients with adenovirus conjunctivitis

    The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis.

    During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

Other Outcomes (5)

  • Seasonality and geographic repartition observed.

    During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

  • Clinical profiles of the patients

    During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)

  • Resource utilization during the treatment and evaluation of the costs

    On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s)

  • +2 more other outcomes

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any female and male patients from one year of age with signs and symptoms of acute conjunctivitis either seen during ophthalmology consultations or who are in the emergency room or hospitalized, can be enrolled in the study

You may qualify if:

  • Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
  • Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
  • No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

You may not qualify if:

  • Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
  • Previous enrolment in the present study.
  • Any direct involvement with the study conduct at site or any family link with study site staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Uwe Pleyer

Berlin, 13353, Germany

Location

Poliklinik Leiter

Cologne, 50937, Germany

Location

University eye hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Florian Seidensticker

Hanover, 30625, Germany

Location

Dr. Thomas Kaercher

Heidelberg, 69121, Germany

Location

Dr. Michael Hyppa

Karlsruhe, 76131, Germany

Location

Städtisches Klinikum Karlsruhe Augenklinik

Karlsruhe, 76133, Germany

Location

Karlheinz Krüger

Karlsruhe, 76229, Germany

Location

Stefan Koinzer

Kiel, 24105, Germany

Location

Katrin Lorenz

Mainz, 55131, Germany

Location

Klinikum der Universität München

München, 80336, Germany

Location

Ulrich Thelen

Münster, 48143, Germany

Location

Ines Lanzl

Prien A. Chiemsee, 83209, Germany

Location

MeSH Terms

Conditions

Conjunctivitis, Viral

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Study Officials

  • Elizabeth M Messmer, MD

    University Hospital Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 4, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

DE(13)