Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
1 other identifier
observational
237
1 country
4
Brief Summary
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedOctober 12, 2020
September 1, 2020
7 months
September 19, 2012
August 13, 2020
September 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
InflammaDry
Patients suspected of having dry eye will be tested with the InflammaDry.
Interventions
Eligibility Criteria
Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.
You may qualify if:
- years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
- Burning or stinging
- Sandy or gritty feeling
- Foreign body sensation
- Tearing
- Light sensitivity
- Intermittent or fluctuating vision
- Tired eyes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Manatee-Sarasota Eye Clinic
Bradenton, Florida, 34208, United States
Mercy Clinic - Eye Specialists
Springfield, Missouri, 65804, United States
Ophthalmic Associates
Johnson City, New York, 13790, United States
Ophthalmology Diagnostics & Clinical Research
El Paso, Texas, 79904-2037, United States
Related Publications (1)
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.
PMID: 24977985DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Sambursky, MD
- Organization
- Rapid Pathogen Screening, Inc.
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
September 19, 2012
First Posted
September 26, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 12, 2020
Results First Posted
October 12, 2020
Record last verified: 2020-09