NCT00266734

Brief Summary

To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis

Trial Health

90
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
2 countries

5 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

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

First QC Date

December 16, 2005

Last Update Submit

February 9, 2010

Conditions

Acute ConjunctivitisAdenoviral Conjunctivitis

Keywords

Adenoviral conjunctivitisViral conjunctivitisconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ability to accurately detect presence or absence of adenovirus in conjunctival specimens

Interventions

RPS Adeno DetectorDEVICE

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Study Enrollment Criteria
  • Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included:
  • I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with "pink eye" within the preceding three weeks
  • II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
  • III. Signs: 1) An inferior palpebral conjunctival reaction with \> or = 1+ papillary or follicular reactions, 2) presence of a preauricular node

You may not qualify if:

  • Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Health Science Center

Denver, Colorado, United States

Location

St Johns Ophthalmology Clinic

Springfield, Missouri, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Erlangen-Nurnberg

Erlangen, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde

Homburg, Germany

Location

MeSH Terms

Conditions

Conjunctivitis, ViralConjunctivitis

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsVirus DiseasesConjunctival DiseasesEye Diseases

Study Officials

  • Elisabeth J Cohen, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

  • Shachar Tauber, MD

    St Johns Ophthalmology Clinic, Springfield, MO

    PRINCIPAL INVESTIGATOR

  • Frank Schirra, MD

    Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany

    PRINCIPAL INVESTIGATOR

  • Kristian Kozich, MD

    University of Erlangen-Nurnberg, Erlangen, Germany

    PRINCIPAL INVESTIGATOR

  • Richard Davidson, MD

    University of Colorado Health Science Center, Denver, CO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 19, 2005

Study Start

December 1, 2004

Study Completion

September 1, 2005

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations

US(3)DE(2)