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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: RPS InflammaDry Detector™

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 Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee Sarasota Eye Clinic
    • Miami, Florida, United States, 33176
      • Center for Excellence in Eye Care
  • Missouri
    • Springfield, Missouri, United States, 65804
      • St. John's Clinics
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • New York, New York, United States, 10016
      • Physician Eyecare of NY
    • New York, New York, United States, 10021
      • Weill-Cornell Medical College
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • El Paso, Texas, United States, 79904-2037
      • William F. Davitt, III, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Only patients who met the inclusion criteria were included in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rapid Pathogen Screening
• Investigators: Study Director: Robert Sambursky, MD, Rapid Pathogen Screening, Inc.

Publications and helpful links

General Publications

• Sambursky R, Davitt WF 3rd, Latkany R, Tauber S, Starr C, Friedberg M, Dirks MS, McDonald M. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8. doi: 10.1001/jamaophthalmol.2013.561. Erratum in: JAMA Ophthalmol. 2013 Mar 1;131(3):364.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Dry eyes; Dysfunctional tear syndrome
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 100310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No