RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.

Conditions
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Dry Eye

Intervention / Treatment
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* Device: RPS InflammaDry Detector™


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device testing<br>Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. | Device: RPS InflammaDry Detector™<br>* A noninvasive immunoassay for detecting MMP-9 levels in tears<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eyes, Dysfunctional tear syndrome