Dry EyeNCT01313351
RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
An observational study of Dry Eye, run by Rapid Pathogen Screening at 8 sites in United States.
Trial summary
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- RPS InflammaDry Detector™
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2010to Oct 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only patients who met the inclusion criteria were included in the study.
Who may be able to join
- Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:
- Group 1: Clinical Dry Eyes
- Clinical History Criteria
- An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - [Appendix #2]
- Clinical Signs Criteria - All of the following must be present
- Schirmer's Tear Test (with anesthesia) < 10 mm over 5 minutes
Show all 16Show fewer
- Tear Film Break Up Time (TBUT) < 10 seconds
- Total Corneal Staining ≥ 1 [Appendix #1]
- At least 1/2 of all patients enrolled will have a Schirmer's Tear Test < 5 mm or demonstrate corneal staining ≥ 2 [Appendix #1]
- Group 2: Clinical Normal Non-Dry Eyes
- Clinical History Criteria
- An Ocular Surface Disease Index (OSDI) of < 7 - [Appendix #2]
- Clinical Signs Criteria - All 3 of the following must be present
- Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
- Tear Film Break Up Time (TBUT) ≥ 10 seconds
- Total Corneal Staining = 0 [Appendix #1]
Who cannot join
- Patients with allergy to corn starch, talcum powder, or dacron
- Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
- Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
- Patients with history of a recent ocular infection within the prior 1 month
- Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
- Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy
Show all 9Show fewer
- Patients who are pregnant or lactating
- Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours
- The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Manatee Sarasota Eye Clinic
Bradenton, Florida, 34208
William F. Davitt, III, MD
El Paso, Texas, 79904-2037
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Center for Excellence in Eye Care
Miami, Florida, 33176
Physician Eyecare of NY
New York, New York, 10016
Weill-Cornell Medical College
New York, New York, 10021
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
St. John's Clinics
Springfield, Missouri, 65804
About this study
Official title: A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Read the detailed description
The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.
Patients were screened using clinical history and signs.
Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:
- positive vital staining of the ocular surface,
- decreased tear breakup time (TBUT),
- reduced corneal sensitivity, and
- decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
- Conditions
- Dry Eye
- Being tested
- RPS InflammaDry Detector™
- Keywords
- Dry eyes, Dysfunctional tear syndrome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPS InflammaDry Detector™Device
A noninvasive immunoassay for detecting MMP-9 levels in tears
| Study group | Role | What they receive |
|---|---|---|
| Device testing | Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. Receives: Device: RPS InflammaDry Detector™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.
Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device.
Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment.
Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.
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 posted11 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 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 Dry EyeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid Pathogen Screening
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Sambursky, MD, Study director, Rapid Pathogen Screening, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313351
- Sponsor's protocol ID
- 100310
- Status last verified
- Nov 2022
- First submitted
- 3 Mar 2011
- Last updated
- 12 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sambursky R, Davitt WF 3rd, Latkany R, Tauber S, Starr C, Friedberg M, Dirks MS, McDonald M. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8. doi: 10.1001/jamaophthalmol.2013.561.
PubMed 23307206
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.
- ClinicalTrials.gov ID
- NCT01313351
- Acronym / sponsor ID
- 100310
- Conditions
- Dry Eye
- Keywords
- Dry eyes, Dysfunctional tear syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Rapid Pathogen ScreeningIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 16 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Detailed description
The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.
Patients were screened using clinical history and signs.
Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:
- positive vital staining of the ocular surface,
- decreased tear breakup time (TBUT),
- reduced corneal sensitivity, and
- decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device testing | – | Device: RPS InflammaDry Detector™Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients who met the inclusion criteria were included in the study.
Key inclusion criteria (16 listed)
- Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:
- Group 1: Clinical Dry Eyes
- Clinical History Criteria
- An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - [Appendix #2]
- Clinical Signs Criteria - All of the following must be present
Key exclusion criteria (9 listed)
- Patients with allergy to corn starch, talcum powder, or dacron
- Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
- Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
- Patients with history of a recent ocular infection within the prior 1 month
- Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
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 InflammaDry Detector™A noninvasive immunoassay for detecting MMP-9 levels in tears | Device | Device testing |
Primary outcome
Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.
Time frame: 15 minutes
Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device. Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment. Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23307206Sambursky R, Davitt WF 3rd, Latkany R, Tauber S, Starr C, Friedberg M, Dirks MS, McDonald M. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8. doi: 10.1001/jamaophthalmol.2013.561.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Robert Sambursky, MD study director
Rapid Pathogen Screening, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, 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 16 inclusion and 9 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 12 Dec 2022. 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 16 Mar 2022). 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 InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. (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 NCT01313351, 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 12 Dec 2022.