Dry Eye
Conditions
Keywords
Dry eyes, Dysfunctional tear syndrome
Brief 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.
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.
Interventions
DEVICERPS InflammaDry Detector™
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
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 1. Schirmer's Tear Test (with anesthesia) \< 10 mm over 5 minutes 2. Tear Film Break Up Time (TBUT) \< 10 seconds 3. 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 1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes 2. Tear Film Break Up Time (TBUT) ≥ 10 seconds 3. Total Corneal Staining = 0 \[Appendix #1\]
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| InflammaDry Test Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.
RPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears | 206 |
| Total | 206 |
Baseline characteristics
| Characteristic | InflammaDry Test |
|---|---|
| Age, Continuous | 53 years |
| Race/Ethnicity, Customized Race Asian | 9 Participants |
| Race/Ethnicity, Customized Race Black | 11 Participants |
| Race/Ethnicity, Customized Race Hispanic | 49 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 136 Participants |
| Region of Enrollment United States | 206 participants |
| Sex: Female, Male Female | 152 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 206 |
| serious Total, serious adverse events | 0 / 206 |
Outcome results
Primary
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.
Time frame: 15 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InflammaDry Sensitivity | Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. | 85 percentage of cases |
| InflammaDry Specificity | Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. | 94 percentage of cases |