A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rapid Pathogen Screening
ClinicalTrials.gov Identifier:
NCT00921895
First received: June 14, 2009
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.


Condition Intervention
Conjunctivitis
Device: RPS Adeno Detector IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.

Resource links provided by NLM:


Further study details as provided by Rapid Pathogen Screening:

Primary Outcome Measures:
  • Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.


Enrollment: 128
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Testing
Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
Device: RPS Adeno Detector IV
One time test with the RPS Adeno Detector IV
Other Name: RPS Adeno Detector IV

Detailed Description:

The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.

  Eligibility

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

Inclusion Criteria:

  • A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
  • Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:

I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)

II Signs: 1) presence of follicles, 2) presence of a preauricular node

III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation

Exclusion Criteria:

  • Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
  • Patients with a corneal ulcer or history of recent trauma will also be excluded.
  • Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
  • Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.
  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: NCT00921895

Locations
United States, Florida
Manatee Eye Clinic
Bradenton, Florida, United States, 34208
Center For Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Missouri
St John's Clinic
Springfield, Missouri, United States, 65804
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Weill-Cornell Medical College
New York, New York, United States, 10021
South Shore Eye Care
Wantagh, New York, United States, 11793
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Northeastern Eye Institute
Scranton, Pennsylvania, United States, 18503
Sponsors and Collaborators
Rapid Pathogen Screening
Investigators
Principal Investigator: Shachar Tauber, MD St John's Clinic
Principal Investigator: Jodi Luchs, MD South Shore Eye Clinic
Principal Investigator: William Trattler, MD Center For Excellence In Eye Care
Principal Investigator: Thomas Boland, MD Northeastern Eye Institute
Principal Investigator: Michael DellaVecchia, MD/PhD Wills Eye Institute
Principal Investigator: Murray Friedberg, MD Manatee Eye Clinic
Principal Investigator: Chris Starr, MD Weill Medical College of Cornell University
Principal Investigator: Marguerite McDonald, MD Ophthalmic Consultants of Long Island
  More Information

No publications provided by Rapid Pathogen Screening

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rapid Pathogen Screening
ClinicalTrials.gov Identifier: NCT00921895     History of Changes
Obsolete Identifiers: NCT00799318
Other Study ID Numbers: 200-003
Study First Received: June 14, 2009
Results First Received: August 22, 2012
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rapid Pathogen Screening:
Pink Eye,
Viral conjunctivitis
Adenoviral conjunctivitis
Keratoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014