Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears

Completed · Not applicable

Conditions studied: Acute Conjunctivitis, Adenoviral Conjunctivitis

In brief

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

Key facts

Study ID

NCT00266734

Run by

Rapid Pathogen Screening

People needed

186

Starts

2004-12-01

Expected to finish

2005-09-01

Last updated by the study team

2010-02-11

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Health Science Center — Denver, Colorado, United States
• St Johns Ophthalmology Clinic — Springfield, Missouri, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• University of Erlangen-Nurnberg — Erlangen, Germany
• Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde — Homburg, Germany

Full record on ClinicalTrials.gov

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