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

NCT ID: NCT00921895

Last Updated: 2021-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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

Conditions

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Conjunctivitis

Keywords

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Pink Eye, Viral conjunctivitis Adenoviral conjunctivitis Keratoconjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Device Testing

Patients with conjunctivitis will be tested with the RPS Adeno Detector IV

Group Type EXPERIMENTAL

RPS Adeno Detector IV

Intervention Type DEVICE

One time test with the RPS Adeno Detector IV

Interventions

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RPS Adeno Detector IV

One time test with the RPS Adeno Detector IV

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rapid Pathogen Screening

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shachar Tauber, MD

Role: PRINCIPAL_INVESTIGATOR

St John's Clinic

Jodi Luchs, MD

Role: PRINCIPAL_INVESTIGATOR

South Shore Eye Clinic

William Trattler, MD

Role: PRINCIPAL_INVESTIGATOR

Center For Excellence In Eye Care

Thomas Boland, MD

Role: PRINCIPAL_INVESTIGATOR

Northeastern Eye Institute

Michael DellaVecchia, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Institute

Murray Friedberg, MD

Role: PRINCIPAL_INVESTIGATOR

Manatee Eye Clinic

Chris Starr, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Marguerite McDonald, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

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Manatee Eye Clinic

Bradenton, Florida, United States

Site Status

Center For Excellence in Eye Care

Miami, Florida, United States

Site Status

St John's Clinic

Springfield, Missouri, United States

Site Status

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Site Status

Weill-Cornell Medical College

New York, New York, United States

Site Status

South Shore Eye Care

Wantagh, New York, United States

Site Status

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Northeastern Eye Institute

Scranton, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23307204 (View on PubMed)

Other Identifiers

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200-003

Identifier Type: -

Identifier Source: org_study_id

NCT00799318

Identifier Type: -

Identifier Source: nct_alias