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

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ClinicalTrials.gov Identifier: NCT00266734
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : February 11, 2010
Information provided by:

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

Condition or disease Intervention/treatment
Acute Conjunctivitis Adenoviral Conjunctivitis Device: RPS Adeno Detector

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
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
Study Start Date : December 2004
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266734

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
University of Erlangen-Nurnberg
Erlangen, Germany
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Homburg, Germany
Sponsors and Collaborators
Rapid Pathogen Screening
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

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
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010

Keywords provided by Rapid Pathogen Screening:
Adenoviral conjunctivitis
Viral conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections