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Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears

Primary Purpose

Acute Conjunctivitis, Adenoviral Conjunctivitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RPS Adeno Detector
Sponsored by
Rapid Pathogen Screening
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Conjunctivitis focused on measuring Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of Colorado Health Science Center
  • St Johns Ophthalmology Clinic
  • Wills Eye Hospital
  • University of Erlangen-Nurnberg
  • Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2005
Last Updated
February 9, 2010
Sponsor
Rapid Pathogen Screening
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1. Study Identification

Unique Protocol Identification Number
NCT00266734
Brief Title
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
Official Title
A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rapid Pathogen Screening

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Conjunctivitis, Adenoviral Conjunctivitis
Keywords
Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
186 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
RPS Adeno Detector
Primary Outcome Measure Information:
Title
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth J Cohen, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shachar Tauber, MD
Organizational Affiliation
St Johns Ophthalmology Clinic, Springfield, MO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Schirra, MD
Organizational Affiliation
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristian Kozich, MD
Organizational Affiliation
University of Erlangen-Nurnberg, Erlangen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Davidson, MD
Organizational Affiliation
University of Colorado Health Science Center, Denver, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Science Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
St Johns Ophthalmology Clinic
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Erlangen-Nurnberg
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
City
Homburg
Country
Germany

12. IPD Sharing Statement

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Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears

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