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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:1 - Any
Updated:4/21/2016
Start Date:June 2009
End Date:June 2011

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

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.

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

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.
We found this trial at
8
sites
Lynbrook, New York 11563
2419
mi
from 98109
Lynbrook, NY
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Bradenton, Florida 34208
2546
mi
from 98109
Bradenton, FL
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Miami, Florida 33176
2730
mi
from 98109
Miami, FL
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New York, New York 10021
2402
mi
from 98109
New York, NY
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Philadelphia, Pennsylvania 19107
2373
mi
from 98109
Philadelphia, PA
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Scranton, Pennsylvania 18503
2303
mi
from 98109
Scranton, PA
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Springfield, Missouri 65807
1633
mi
from 98109
Springfield, MO
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Wantagh, New York
2426
mi
from 98109
Wantagh, NY
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