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

Not Applicable

Completed

• Conditions: Conjunctivitis

• Registration Number: NCT00921895
• Lead Sponsor: Rapid Pathogen Screening

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-14
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-08-22
• Results First Submitted QC: 2012-08-22
• Results First Posted: 2012-08-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.	15 minutes	Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.

Trial Locations

Locations (8)

Manatee Eye Clinic; 🇺🇸 Bradenton, Florida, United States

Center For Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

St John's Clinic; 🇺🇸 Springfield, Missouri, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Lynbrook, New York, United States

Weill-Cornell Medical College; 🇺🇸 New York, New York, United States

South Shore Eye Care; 🇺🇸 Wantagh, New York, United States

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Northeastern Eye Institute; 🇺🇸 Scranton, Pennsylvania, United States