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

Adenoviral Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266734
• Other study ID #: IRB# 03-543E
• Secondary ID: St John's IRB# 0
• Status: Completed
• Phase: N/A
• First received: December 16, 2005
• Last updated: February 9, 2010
• Start date: December 2004
• Est. completion date: September 2005

Study information

• Verified date: February 2010
• Source: Rapid Pathogen Screening
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Conjunctivitis
• Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Device:
• RPS Adeno Detector

Locations

Country	Name	City	State
Germany	University of Erlangen-Nurnberg	Erlangen
Germany	Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde	Homburg
United States	University of Colorado Health Science Center	Denver	Colorado
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	St Johns Ophthalmology Clinic	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Pathogen Screening

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to accurately detect presence or absence of adenovirus in conjunctival specimens