Dysfunctional Tear Syndrome
Conditions
Keywords
Dry Eye
Brief summary
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.
Interventions
DEVICEInflammaDry
A noninvasive immunoassay for detecting MMP-9 levels in tears.
Sponsors
Rapid Pathogen Screening
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month: 1. Burning or stinging 2. Sandy or gritty feeling 3. Foreign body sensation 4. Tearing 5. Light sensitivity 6. Intermittent or fluctuating vision 7. Tired eyes
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | 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. |
Countries
United States
Participant flow
Recruitment details
The recruitment took place over a 7-month period. The study was performed at private practices and academic centers.
Participants by arm
| Arm | Count |
|---|---|
| InflammaDry Patients suspected of having dry eye will be tested with the InflammaDry.
InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears. | 237 |
| Total | 237 |
Baseline characteristics
| Characteristic | InflammaDry |
|---|---|
| Age, Customized | 53 years |
| Region of Enrollment United States | 237 participants |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 237 |
| serious Total, serious adverse events | 0 / 237 |
Outcome results
Primary
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.
Time frame: 20 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| InflammaDry (Sensitivity) | Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | Confirmatory Testing With OSDI Inclusion | 81 percentage of cases |
| InflammaDry (Sensitivity) | Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | Confirmatory Testing Without OSDI Inclusion | 86 percentage of cases |
| Inflammadry (Specificity) | Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | Confirmatory Testing With OSDI Inclusion | 98 percentage of cases |
| Inflammadry (Specificity) | Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | Confirmatory Testing Without OSDI Inclusion | 97 percentage of cases |