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

NCT00921895 | Completed Results

• 1 other identifier: 200-003
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 8

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.

Conditions

Conjunctivitis

Keywords

Pink Eye,; Viral conjunctivitis; Adenoviral conjunctivitis; Keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.

  Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.

  15 minutes

Study Arms (1)

Device Testing

EXPERIMENTAL

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

Device: RPS Adeno Detector IV

Interventions

RPS Adeno Detector IV DEVICE

One time test with the RPS Adeno Detector IV

Device Testing

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rapid Pathogen Screening: lead

Study Sites (8)

Manatee Eye Clinic

Bradenton, Florida, 34208, United States

Location

Center For Excellence in Eye Care

Miami, Florida, 33176, United States

Location

St John's Clinic

Springfield, Missouri, 65804, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Weill-Cornell Medical College

New York, New York, 10021, United States

Location

South Shore Eye Care

Wantagh, New York, 11793, United States

Location

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Northeastern Eye Institute

Scranton, Pennsylvania, 18503, United States

Location

Related Publications (1)

• 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.

  PMID: 23307204 DERIVED

MeSH Terms

Conditions

Conjunctivitis; Conjunctivitis, Viral; Keratoconjunctivitis

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Eye Infections, Viral; Eye Infections; Infections; Virus Diseases; Keratitis; Corneal Diseases

Results Point of Contact

• Title: Robert Sambusky, MD
• Organization: Rapid Pathogen Screening, Inc.

sambursky@rpsdetectors.com

941-556-1853

Study Officials

• Shachar Tauber, MD

  St John's Clinic

  PRINCIPAL INVESTIGATOR

• Jodi Luchs, MD

  South Shore Eye Clinic

  PRINCIPAL INVESTIGATOR

• William Trattler, MD

  Center For Excellence In Eye Care

  PRINCIPAL INVESTIGATOR

• Thomas Boland, MD

  Northeastern Eye Institute

  PRINCIPAL INVESTIGATOR

• Michael DellaVecchia, MD/PhD

  Wills Eye Institute

  PRINCIPAL INVESTIGATOR

• Murray Friedberg, MD

  Manatee Eye Clinic

  PRINCIPAL INVESTIGATOR

• Chris Starr, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Marguerite McDonald, MD

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 3, 2021
• Results First Posted: August 24, 2012

Record last verified: 2021-11

Locations

US (8)