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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01313351
Other study ID # 100310
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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