Clinical trial NCT00266734: Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
Official title: A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Conjunctivitis
Adenoviral Conjunctivitis
Keywords: Adenoviral conjunctivitis
Viral conjunctivitis
conjunctivitis
Lead sponsor: RapidPS
Sponsor class: UNKNOWN
First posted: 2005-12-19
Enrollment: 186
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Springfield
country: United States
facility: St Johns Ophthalmology Clinic
state: Missouri
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Erlangen
country: Germany
facility: University of Erlangen-Nurnberg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Study officials:
affiliation: Wills Eye Hospital
name: Elisabeth J Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Johns Ophthalmology Clinic, Springfield, MO
name: Shachar Tauber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany
name: Frank Schirra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nurnberg, Erlangen, Germany
name: Kristian Kozich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Health Science Center, Denver, CO
name: Richard Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: