NCT00266734CompletedNot Applicable
A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis
Rapid Pathogen Screening6 sites in 2 countries186 target enrollmentStarted: December 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 186
- Locations
- 6
- Primary Endpoint
- Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
Study Overview
Brief Summary
To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single
Eligibility Criteria
- Ages
- 1 Month to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical Study Enrollment Criteria
- •Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included:
- •I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with "pink eye" within the preceding three weeks
- •II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
- •III. Signs: 1) An inferior palpebral conjunctival reaction with > or = 1+ papillary or follicular reactions, 2) presence of a preauricular node
Exclusion Criteria
- •Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application
Outcomes
Primary Outcomes
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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