Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT00266734
Status:
COMPLETED
Last Update Posted:
2010-02-11
First Post:
2005-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003236', 'term': 'Conjunctivitis, Viral'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2010-02-09', 'studyFirstSubmitDate': '2005-12-16', 'studyFirstSubmitQcDate': '2005-12-16', 'lastUpdatePostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to accurately detect presence or absence of adenovirus in conjunctival specimens'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adenoviral conjunctivitis', 'Viral conjunctivitis', 'conjunctivitis'], 'conditions': ['Acute Conjunctivitis', 'Adenoviral Conjunctivitis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical Study Enrollment Criteria\n\nUpon 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:\n\nI. 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\n\nII. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation\n\nIII. Signs: 1) An inferior palpebral conjunctival reaction with \\> or = 1+ papillary or follicular reactions, 2) presence of a preauricular node\n\nExclusion Criteria:\n\nPatients 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'}, 'identificationModule': {'nctId': 'NCT00266734', 'briefTitle': 'Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears', 'organization': {'class': 'UNKNOWN', 'fullName': 'RapidPS'}, 'officialTitle': 'A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis', 'orgStudyIdInfo': {'id': 'IRB# 03-543E'}, 'secondaryIdInfos': [{'id': "St John's IRB# 00003995"}, {'id': 'Colorado HSC IRB# 05-0151'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'RPS Adeno Detector', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Johns Ophthalmology Clinic', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen-Nurnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Elisabeth J Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}, {'name': 'Shachar Tauber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Johns Ophthalmology Clinic, Springfield, MO'}, {'name': 'Frank Schirra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany'}, {'name': 'Kristian Kozich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nurnberg, Erlangen, Germany'}, {'name': 'Richard Davidson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Health Science Center, Denver, CO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapid Pathogen Screening', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robert Sambursky', 'oldOrganization': 'Rapid Pathogen Screening, Inc'}}}}