N/A
N=128
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00921895 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. — 90; 96 percentage of cases
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RPS Adeno Detector IV (Device)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Rapid Pathogen Screening
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. |
90; 96 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00921895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.