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

A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00266734

Enrollment

186

Registered

2005-12-19

Start date

2004-12-31

Completion date

2005-09-30

Last updated

2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Conjunctivitis, Adenoviral Conjunctivitis

Keywords

Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis

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

Interventions

DEVICERPS Adeno Detector

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

1 Months to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026