Clinical trial NCT00921895: A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctivitis
Keywords: Pink Eye,
Viral conjunctivitis
Adenoviral conjunctivitis
Keratoconjunctivitis
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Manatee Eye Clinic
state: Florida
city: Miami
country: United States
facility: Center For Excellence in Eye Care
state: Florida
city: Springfield
country: United States
facility: St John's Clinic
state: Missouri
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: New York
country: United States
facility: Weill-Cornell Medical College
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care
state: New York
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
city: Scranton
country: United States
facility: Northeastern Eye Institute
state: Pennsylvania
Study officials:
affiliation: St John's Clinic
name: Shachar Tauber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Shore Eye Clinic
name: Jodi Luchs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center For Excellence In Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern Eye Institute
name: Thomas Boland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wills Eye Institute
name: Michael DellaVecchia, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manatee Eye Clinic
name: Murray Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Chris Starr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Long Island
name: Marguerite McDonald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513.