Acute ConjunctivitisNCT00266734
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
A study testing RPS Adeno Detector in people with Acute Conjunctivitis and Adenoviral Conjunctivitis, run by Rapid Pathogen Screening at 5 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Acute Conjunctivitis, Adenoviral Conjunctivitis
- What is being tested?
- RPS Adeno Detector
- Type of treatment
- Medical device
- How many people
- 186 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2004to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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
- Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
- Signs: 1) An inferior palpebral conjunctival reaction with > or = 1+ papillary or follicular reactions, 2) presence of a preauricular node
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
University of Colorado Health Science Center
Denver, Colorado
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
St Johns Ophthalmology Clinic
Springfield, Missouri
Germany2 sites
University of Erlangen-Nurnberg
Erlangen
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde
Homburg
About this study
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
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
- Conditions
- Acute Conjunctivitis, Adenoviral Conjunctivitis
- Being tested
- RPS Adeno Detector
- Keywords
- Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis
- Medical subject headings
- Conjunctivitis, Viral, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPS Adeno DetectorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 186 participants
Sponsor and investigators
- Lead sponsor
- Rapid Pathogen Screening
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elisabeth J Cohen, MD, Principal investigator, Wills Eye HospitalShachar Tauber, MD, Principal investigator, St Johns Ophthalmology Clinic, Springfield, MOFrank Schirra, MD, Principal investigator, Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, GermanyKristian Kozich, MD, Principal investigator, University of Erlangen-Nurnberg, Erlangen, GermanyRichard Davidson, MD, Principal investigator, University of Colorado Health Science Center, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266734
- Sponsor's protocol ID
- IRB# 03-543E
- Other IDs
- St John's IRB# 00003995, Colorado HSC IRB# 05-0151
- Status last verified
- Feb 2010
- First submitted
- 16 Dec 2005
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00266734
- Acronym / sponsor ID
- IRB# 03-543E
- Conditions
- Acute Conjunctivitis, Adenoviral Conjunctivitis
- Keywords
- Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants
- Lead sponsor
- Rapid Pathogen ScreeningIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Sep 2005
- First posted
- 19 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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
- Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
- Signs: 1) An inferior palpebral conjunctival reaction with > or = 1+ papillary or follicular reactions, 2) presence of a preauricular node
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPS Adeno Detector | Device | – |
Primary outcome
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth J Cohen, MD principal investigator
Wills Eye Hospital
Shachar Tauber, MD principal investigator
St Johns Ophthalmology Clinic, Springfield, MO
Frank Schirra, MD principal investigator
Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, Germany
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPS Adeno Detector in people with Acute Conjunctivitis and Adenoviral Conjunctivitis, run by Rapid Pathogen Screening at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to accurately detect presence or absence of adenovirus in conjunctival specimens. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2010.