Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.

Study Overview

• Status: Completed
• Conditions: Dysfunctional Tear Syndrome
• Intervention / Treatment: Device: InflammaDry

Detailed Description

The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

• Study Type: Observational
• Enrollment (Actual): 237

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee-Sarasota Eye Clinic
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic - Eye Specialists
  • New York
    • Johnson City, New York, United States, 13790
      • Ophthalmic Associates
  • Texas
    • El Paso, Texas, United States, 79904-2037
      • Ophthalmology Diagnostics & Clinical Research

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

Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.

Description

Inclusion Criteria:

• 18 years of age or older

• Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:

  1. Burning or stinging
  2. Sandy or gritty feeling
  3. Foreign body sensation
  4. Tearing
  5. Light sensitivity
  6. Intermittent or fluctuating vision
  7. Tired eyes

Exclusion Criteria

• Allergy to cornstarch or Dacron
• Allergy to topical anesthetic or fluorescein dye
• Prior eye injury, trauma, or ocular surgery within the last 3 months
• Known blockage of the lacrimal drainage system
• Contact lens wear in the last month
• Previous corneal refractive surgery including RK, LASIK or PRK surgery
• Have an active ocular infection or history of a recent ocular infection in the last month
• Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
• Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
• Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
• Pregnant or lactating
• Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment

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
InflammaDry; Patients suspected of having dry eye will be tested with the InflammaDry.	Device: InflammaDry; A noninvasive immunoassay for detecting MMP-9 levels in tears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes	Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.	20 minutes

Collaborators and Investigators

• Sponsor: Rapid Pathogen Screening

Publications and helpful links

General Publications

• Sambursky R, Davitt WF 3rd, Friedberg M, Tauber S. Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease. Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dry Eye
• Other Study ID Numbers: 12-0615