Conjunctivitis Clinical Trial
Official title:
A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
NCT number | NCT00921895 |
Other study ID # | 200-003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | June 2011 |
Verified date | November 2021 |
Source | Lumos Diagnostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Manatee Eye Clinic | Bradenton | Florida |
United States | Ophthalmic Consultants of Long Island | Lynbrook | New York |
United States | Center For Excellence in Eye Care | Miami | Florida |
United States | Weill-Cornell Medical College | New York | New York |
United States | Wills Eye Institute | Philadelphia | Pennsylvania |
United States | Northeastern Eye Institute | Scranton | Pennsylvania |
United States | St John's Clinic | Springfield | Missouri |
United States | South Shore Eye Care | Wantagh | New York |
Lead Sponsor | Collaborator |
---|---|
Rapid Pathogen Screening |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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