ConjunctivitisNCT00921895
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
A study testing RPS Adeno Detector IV in people with Conjunctivitis, run by Rapid Pathogen Screening at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Conjunctivitis
- What is being tested?
- RPS Adeno Detector IV
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Manatee Eye Clinic
Bradenton, Florida, 34208
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Center For Excellence in Eye Care
Miami, Florida, 33176
Weill-Cornell Medical College
New York, New York, 10021
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Northeastern Eye Institute
Scranton, Pennsylvania, 18503
St John's Clinic
Springfield, Missouri, 65804
South Shore Eye Care
Wantagh, New York, 11793
About this study
Official title: A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
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.
Read the detailed description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
- Conditions
- Conjunctivitis
- Being tested
- RPS Adeno Detector IV
- Keywords
- Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis
- Medical subject headings
- Conjunctivitis, Conjunctivitis, Viral, Keratoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPS Adeno Detector IVDevice
One time test with the RPS Adeno Detector IV
| Study group | Role | What they receive |
|---|---|---|
| Device Testing | Experimental | Patients with conjunctivitis will be tested with the RPS Adeno Detector IV Receives: Device: RPS Adeno Detector IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid Pathogen Screening
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shachar Tauber, MD, Principal investigator, St John's ClinicJodi Luchs, MD, Principal investigator, South Shore Eye ClinicWilliam Trattler, MD, Principal investigator, Center For Excellence In Eye CareThomas Boland, MD, Principal investigator, Northeastern Eye InstituteMichael DellaVecchia, MD/PhD, Principal investigator, Wills Eye InstituteMurray Friedberg, MD, Principal investigator, Manatee Eye ClinicChris Starr, MD, Principal investigator, Weill Medical College of Cornell UniversityMarguerite McDonald, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921895
- Sponsor's protocol ID
- 200-003
- Status last verified
- Nov 2021
- First submitted
- 14 Jun 2009
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513.
PubMed 23307204
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
- ClinicalTrials.gov ID
- NCT00921895
- Acronym / sponsor ID
- 200-003
- Conditions
- Conjunctivitis
- Keywords
- Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Rapid Pathogen ScreeningIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Posted 24 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Testing | Experimental | Device: RPS Adeno Detector IVPatients with conjunctivitis will be tested with the RPS Adeno Detector IV |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 IVOne time test with the RPS Adeno Detector IV | Device | Device Testing |
Primary outcome
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.
Time frame: 15 minutes
Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23307204Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513.
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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.
Shachar Tauber, MD principal investigator
St John's Clinic
Jodi Luchs, MD principal investigator
South Shore Eye Clinic
William Trattler, MD principal investigator
Center For Excellence In Eye Care
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPS Adeno Detector IV in people with Conjunctivitis, run by Rapid Pathogen Screening at 8 sites in United States.
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 4 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921895, which also lists 1 linked publication.
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 3 Nov 2021.