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OpenTrials
Completed

NCT Number: NCT00921895

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

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manatee Eye Clinic, Bradenton, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RPS Adeno Detector IV

Device

One time test with the RPS Adeno Detector IV

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rapid Pathogen Screening

Industry

Registry information

Official study title

A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2009
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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