Dysfunctional Tear SyndromeNCT01692964
Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
An observational study of Dysfunctional Tear Syndrome, run by Rapid Pathogen Screening at 4 sites in United States.
Trial summary
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysfunctional Tear Syndrome
- What is being tested?
- InflammaDry
- Type of treatment
- Medical device
- How many people
- 237 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2012to May 2013
- 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: Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.
Who may be able to join
- 18 years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
- Burning or stinging
- Sandy or gritty feeling
- Foreign body sensation
- Tearing
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- Light sensitivity
- Intermittent or fluctuating vision
- Tired eyes
Who cannot join
- Allergy to cornstarch or Dacron
- Allergy to topical anesthetic or fluorescein dye
- Prior eye injury, trauma, or ocular surgery within the last 3 months
- Known blockage of the lacrimal drainage system
- Contact lens wear in the last month
- Previous corneal refractive surgery including RK, LASIK or PRK surgery
Show all 12Show fewer
- Have an active ocular infection or history of a recent ocular infection in the last month
- Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
- Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
- Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
- Pregnant or lactating
- Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Manatee-Sarasota Eye Clinic
Bradenton, Florida, 34208
Ophthalmology Diagnostics & Clinical Research
El Paso, Texas, 79904-2037
Ophthalmic Associates
Johnson City, New York, 13790
Mercy Clinic - Eye Specialists
Springfield, Missouri, 65804
About this study
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Read the detailed description
The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.
- Conditions
- Dysfunctional Tear Syndrome
- Being tested
- InflammaDry
- Keywords
- Dry Eye
- 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.
InflammaDryDevice
A noninvasive immunoassay for detecting MMP-9 levels in tears.
| Study group | Role | What they receive |
|---|---|---|
| InflammaDry | Patients suspected of having dry eye will be tested with the InflammaDry. Receives: Device: InflammaDry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Dysfunctional Tear SyndromeStudies 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapid Pathogen Screening
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692964
- Sponsor's protocol ID
- 12-0615
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2012
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sambursky R, Davitt WF 3rd, Friedberg M, Tauber S. Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease. Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.
PubMed 24977985
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
- ClinicalTrials.gov ID
- NCT01692964
- Acronym / sponsor ID
- 12-0615
- Conditions
- Dysfunctional Tear Syndrome
- Keywords
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Rapid Pathogen ScreeningIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Detailed description
The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InflammaDry | – | Device: InflammaDryPatients suspected of having dry eye will be tested with the InflammaDry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.
Key inclusion criteria (9 listed)
- 18 years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
Key exclusion criteria (12 listed)
- Allergy to cornstarch or Dacron
- Allergy to topical anesthetic or fluorescein dye
- Prior eye injury, trauma, or ocular surgery within the last 3 months
- Known blockage of the lacrimal drainage system
- Contact lens wear in the last 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 |
|---|---|---|
| InflammaDryA noninvasive immunoassay for detecting MMP-9 levels in tears. | Device | InflammaDry |
Primary outcome
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
Time frame: 20 minutes
Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24977985Sambursky R, Davitt WF 3rd, Friedberg M, Tauber S. Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease. Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunctional Tear Syndrome, run by Rapid Pathogen Screening at 4 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 9 inclusion and 12 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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 12 Oct 2020). 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?
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes (time frame: 20 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 NCT01692964, 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 Oct 2020.