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

This study has been completed.
Sponsor:
Information provided by:
Rapid Pathogen Screening
ClinicalTrials.gov Identifier:
NCT00266734
First received: December 16, 2005
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention
Acute Conjunctivitis
Adenoviral Conjunctivitis
Device: RPS Adeno Detector

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

Resource links provided by NLM:


Further study details as provided by Rapid Pathogen Screening:

Primary Outcome Measures:
  • Ability to accurately detect presence or absence of adenovirus in conjunctival specimens

Estimated Enrollment: 186
Study Start Date: December 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266734

Locations
United States, Colorado
University of Colorado Health Science Center
Denver, Colorado, United States
United States, Missouri
St Johns Ophthalmology Clinic
Springfield, Missouri, United States
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Germany
University of Erlangen-Nurnberg
Erlangen, Germany
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Homburg, Germany
Sponsors and Collaborators
Rapid Pathogen Screening
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Robert Sambursky, Rapid Pathogen Screening, Inc
ClinicalTrials.gov Identifier: NCT00266734     History of Changes
Other Study ID Numbers: IRB# 03-543E, St John's IRB# 00003995, Colorado HSC IRB# 05-0151
Study First Received: December 16, 2005
Last Updated: February 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rapid Pathogen Screening:
Adenoviral conjunctivitis
Viral conjunctivitis
conjunctivitis

Additional relevant MeSH terms:
Acute Disease
Conjunctivitis
Conjunctival Diseases
Disease Attributes
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014