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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313351
• Other study ID #: 100310
• Status: Completed
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2022
• Source: Lumos Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• RPS InflammaDry Detector™
A noninvasive immunoassay for detecting MMP-9 levels in tears

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	15 minutes