Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00921895
Other study ID # 200-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date June 2011

Study information

Verified date November 2021
Source Lumos Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.


Description:

The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.


Other known NCT identifiers
  • NCT00799318

Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria: - A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study. - Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below: I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI) II Signs: 1) presence of follicles, 2) presence of a preauricular node III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation Exclusion Criteria: - Patients with allergy to corn starch, talcum powder, or dacron will be excluded. - Patients with a corneal ulcer or history of recent trauma will also be excluded. - Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded. - Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RPS Adeno Detector IV
One time test with the RPS Adeno Detector IV

Locations

Country Name City State
United States Manatee Eye Clinic Bradenton Florida
United States Ophthalmic Consultants of Long Island Lynbrook New York
United States Center For Excellence in Eye Care Miami Florida
United States Weill-Cornell Medical College New York New York
United States Wills Eye Institute Philadelphia Pennsylvania
United States Northeastern Eye Institute Scranton Pennsylvania
United States St John's Clinic Springfield Missouri
United States South Shore Eye Care Wantagh New York

Sponsors (1)

Lead Sponsor Collaborator
Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture. 15 minutes
See also
  Status Clinical Trial Phase
Completed NCT00783198 - Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED) Phase 2/Phase 3
Completed NCT00770315 - Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234) Phase 3
Recruiting NCT06229379 - The Effects of a Large Language Model on Clinical Questioning Skills N/A
Not yet recruiting NCT03631108 - Feasibility Study and Preliminary Application Study on Iris OCTA
Completed NCT01028027 - Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis Phase 3
Completed NCT00978029 - Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081) Phase 2
Completed NCT00562159 - Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) Phase 3
Completed NCT00550550 - Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) Phase 3
Withdrawn NCT02795273 - Efficacy and Safety of Grass-SPIRE Registration Study Phase 2/Phase 3
Not yet recruiting NCT01600365 - Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus Phase 3
Completed NCT00567918 - Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis Phase 3
Completed NCT04374656 - Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic
Completed NCT03753893 - Ocular Manifestations in Rheumatic Diseases
Completed NCT02472223 - Reducing Adenoviral Patient Infected Days N/A
Completed NCT00001734 - Screening for NEI Clinical Studies N/A
Completed NCT00623701 - Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation Phase 3
Completed NCT00581542 - Moxifloxacin vs. Polytrim for Conjunctivitis Phase 4
Completed NCT04287608 - Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Completed NCT04984941 - Evaluation of the Role of IgE Responses to Der p 1 and Der p 2 in Chinese House Dust Mite-Allergic Patients
Completed NCT01385371 - A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067) Phase 3