Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Testing | Experimental | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPS Adeno Detector IV | Device | One time test with the RPS Adeno Detector IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manatee Eye Clinic | Bradenton | Florida | 34208 | United States | ||
| Center For Excellence in Eye Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23307204 | Derived | 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. |
Not provided
Not provided
Not provided
The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Device Testing | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami |
| Florida |
| 33176 |
| United States |
| St John's Clinic | Springfield | Missouri | 65804 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Weill-Cornell Medical College | New York | New York | 10021 | United States |
| South Shore Eye Care | Wantagh | New York | 11793 | United States |
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Northeastern Eye Institute | Scranton | Pennsylvania | 18503 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Device Testing | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percentage of cases | 15 minutes |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Testing | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV | 0 | 128 | 0 | 128 |
Not provided
Not provided
Results to be published or presented shall be submitted to RPS for review and comment at least 30 days prior to submission for publication or presentation. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after RPS confirms there will be no multicenter study publication, whichever occurs first.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Sambusky, MD | Rapid Pathogen Screening, Inc. | 941-556-1853 | sambursky@rpsdetectors.com |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003236 | Conjunctivitis, Viral |
| D007637 | Keratoconjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
Not provided
Not provided