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

NCT ID: NCT00266734

Last Updated: 2010-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-09-30

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

Conditions

Acute Conjunctivitis; Adenoviral Conjunctivitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

RPS Adeno Detector

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rapid Pathogen Screening

INDUSTRY

Sponsor Role: lead

Responsible Party

Rapid Pathogen Screening, Inc

Principal Investigators

Elisabeth J Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Shachar Tauber, MD

Role: PRINCIPAL_INVESTIGATOR

St Johns Ophthalmology Clinic, Springfield, MO

Frank Schirra, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany

Kristian Kozich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nurnberg, Erlangen, Germany

Richard Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Health Science Center, Denver, CO

Locations

University of Colorado Health Science Center

Denver, Colorado, United States

St Johns Ophthalmology Clinic

Springfield, Missouri, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

University of Erlangen-Nurnberg

Erlangen, , Germany

Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde

Homburg, , Germany

Countries

United States; Germany

Other Identifiers

St John's IRB# 00003995

Identifier Type: -

Identifier Source: secondary_id

Colorado HSC IRB# 05-0151

Identifier Type: -

Identifier Source: secondary_id

IRB# 03-543E

Identifier Type: -

Identifier Source: org_study_id