RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Device testing Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. |
Device: RPS InflammaDry Detector™
A noninvasive immunoassay for detecting MMP-9 levels in tears
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
-
Schirmer's Tear Test (with anesthesia) < 10 mm over 5 minutes
-
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]
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manatee Sarasota Eye Clinic | Bradenton | Florida | United States | 34208 |
| 2 | Center for Excellence in Eye Care | Miami | Florida | United States | 33176 |
| 3 | St. John's Clinics | Springfield | Missouri | United States | 65804 |
| 4 | Ophthalmic Consultants of Long Island | Lynbrook | New York | United States | 11563 |
| 5 | Physician Eyecare of NY | New York | New York | United States | 10016 |
| 6 | Weill-Cornell Medical College | New York | New York | United States | 10021 |
| 7 | Black Hills Regional Eye Institute | Rapid City | South Dakota | United States | 57701 |
| 8 | William F. Davitt, III, MD | El Paso | Texas | United States | 79904-2037 |
Sponsors and Collaborators
- Rapid Pathogen Screening
Investigators
- Study Director: Robert Sambursky, MD, Rapid Pathogen Screening, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 100310
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Device Testing |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 206 |
| COMPLETED | 206 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | InflammaDry Test |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 206 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
53
|
| Sex: Female, Male (Count of Participants) | |
| Female |
152
73.8%
|
| Male |
54
26.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White |
136
66%
|
| Black |
11
5.3%
|
| Hispanic |
49
23.8%
|
| Asian |
9
4.4%
|
| Other |
1
0.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
206
100%
|
Outcome Measures
| Title | Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | InflammaDry Sensitivity | InflammaDry Specificity |
|---|---|---|
| Arm/Group Description | Percentage of True Positives when compared to Clinical Assessment | Percentage of True Negatives when compared to Clinical Assessment |
| Measure Participants | 143 | 63 |
| Number (95% Confidence Interval) [percentage of cases] |
85
|
94
|
Adverse Events
| Time Frame | 15 minutes | |
|---|---|---|
| Adverse Event Reporting Description | Regular monitoring by sponsor and mandatory reporting by investigator | |
| Arm/Group Title | Device Testing | |
| Arm/Group Description | No adverse events reported | |
All Cause Mortality |
||
| Device Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Device Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/206 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Device Testing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/206 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
Results Point of Contact
| Name/Title | Robert Sambursky, MD |
|---|---|
| Organization | Rapid Pathogen Screening, Inc |
| Phone | 9415581853 |
| rob.sambursky@lumosdiagnostics.com |
- 100310