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

NCT01313351 | Completed Results

• 1 other identifier: 100310
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 8

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.

Conditions

Dry Eye

Keywords

Dry eyes; Dysfunctional tear syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Device testing

Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.

Device: RPS InflammaDry Detector™

Interventions

RPS InflammaDry Detector™ DEVICE

A noninvasive immunoassay for detecting MMP-9 levels in tears

Device testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rapid Pathogen Screening: lead

Study Sites (8)

Manatee Sarasota Eye Clinic

Bradenton, Florida, 34208, United States

Location

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

St. John's Clinics

Springfield, Missouri, 65804, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Physician Eyecare of NY

New York, New York, 10016, United States

Location

Weill-Cornell Medical College

New York, New York, 10021, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

William F. Davitt, III, MD

El Paso, Texas, 79904-2037, United States

Location

Related Publications (1)

• 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.

  PMID: 23307206 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Robert Sambursky, MD
• Organization: Rapid Pathogen Screening, Inc

rob.sambursky@lumosdiagnostics.com

9415581853

Study Officials

• Robert Sambursky, MD

  Rapid Pathogen Screening, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 11, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 12, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-11

Locations

US (8)