RPS Adeno Detector HS for Diagnosing Adenoviral Conjunctivitis - Full Text View

Sponsored by:	Rapid Pathogen Screening
Information provided by:	Rapid Pathogen Screening
ClinicalTrials.gov Identifier:	NCT00799318

Purpose

The RPS Adeno Detector HS will be demonstrated to be more sensitive and specific than the RPS Adeno Detector™.

Condition	Intervention
Conjunctivitis	Device: Immunoassay

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Comparison Between the RPS Adeno Detector HS and the RPS Adeno Detector for Diagnosing Adenoviral Conjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Further study details as provided by Rapid Pathogen Screening:

Primary Outcome Measures:

The efficacy (sensitivity and specificity) of the RPS Adeno Detector HS at correctly identifying the presence of adenoviral conjunctivitis [ Time Frame: Initial visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of performing the RPS Adeno Detector HS [ Time Frame: Initial visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

RPS Adeno Detector HS and RPS Adeno Detector used to sample tears

Detailed Description:

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive rapid pathogen screening test, the RPS Adeno Detector HS's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to both the RPS Adeno Detector™ and the polymerase chain reaction (PCR).

Currently, acute conjunctivitis is primarily a clinical diagnosis. Cultures are rarely performed due to the significant time delay in receiving results. Recently, the RPS Adeno Detector™ was both FDA cleared and CLIA waived. It is an antigen-based immunoassay that has the ability to detect the presence of ADV at the point of care. RPS Inc has made modifications to the sampling to pad and test strip to facilitate better antigen collection and release, respectively. It is believed that these changes will lead to better sensitivity, specificity, and ease of use of the test.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with a possible 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:
History:
1. Spread from 1 eye to the other several days later
2. A recent history of an upper respiratory infection (URI)
Signs:
1. Presence of follicles
2. Presence of a preauricular node
Symptoms:
1. Watery - purulent discharge
2. Eyelash matting
3. Itching
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799318

Locations

United States, Florida
Manatee Eye Clinic
Bradenton, Florida, United States, 34208
Center for Excellence
Miami, Florida, United States
United States, Missouri
St John's Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rapid Pathogen Screening

More Information

No publications provided

Responsible Party:	Rapid Pathogen Screening, Inc ( Robert Sambursky, MD )
Study ID Numbers:	200-003, 07C.320 TJU
Study First Received:	November 5, 2008
Last Updated:	March 15, 2009
ClinicalTrials.gov Identifier:	NCT00799318 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rapid Pathogen Screening:

Adenovirus
Conjunctivitis
RPS Adeno Detector
Adenoviral Conjunctivitis

Study placed in the following topic categories:

Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Conjunctivitis, Inclusion
Eye Diseases
Adenoviridae Infections

Chlamydia Infections
Eye Infections
Conjunctivitis
Conjunctival Diseases
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Chlamydiaceae Infections
Conjunctivitis, Inclusion
Eye Diseases

Eye Infections
Chlamydia Infections
Conjunctivitis
Infection
Conjunctival Diseases
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 10, 2009