Status:
COMPLETED
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Lead Sponsor:
Rapid Pathogen Screening
Conditions:
Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
NA
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)...
Detailed Description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00921895
Start Date
June 1 2009
End Date
June 1 2011
Last Update
November 3 2021
Active Locations (8)
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1
Manatee Eye Clinic
Bradenton, Florida, United States, 34208
2
Center For Excellence in Eye Care
Miami, Florida, United States, 33176
3
St John's Clinic
Springfield, Missouri, United States, 65804
4
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563