Status:
COMPLETED
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
Lead Sponsor:
Rapid Pathogen Screening
Conditions:
Acute Conjunctivitis
Adenoviral Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
NA
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00266734
Start Date
December 1 2004
End Date
September 1 2005
Last Update
February 11 2010
Active Locations (5)
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1
University of Colorado Health Science Center
Denver, Colorado, United States
2
St Johns Ophthalmology Clinic
Springfield, Missouri, United States
3
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
4
University of Erlangen-Nurnberg
Erlangen, Germany