Conjunctivitis
Conditions
Keywords
Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis
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) 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.
Detailed description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Interventions
DEVICERPS Adeno Detector IV
One time test with the RPS Adeno Detector IV
Sponsors
Rapid Pathogen Screening
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. | 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. |
Countries
United States
Participant flow
Recruitment details
The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers.
Participants by arm
| Arm | Count |
|---|---|
| Device Testing Patients with conjunctivitis will be tested with the RPS Adeno Detector IV | 128 |
| Total | 128 |
Baseline characteristics
| Characteristic | Device Testing |
|---|---|
| Age, Customized | 43 years |
| Region of Enrollment United States | 128 participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
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.
Time frame: 15 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPS Adeno Detector IV (Sensitivity) | Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. | 90 percentage of cases |
| RPS Adeno Detector IV (Specificity) | Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. | 96 percentage of cases |