Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Completed

• Conditions: Dysfunctional Tear Syndrome
• Interventions: Device: InflammaDry

• Registration Number: NCT01692964
• Lead Sponsor: Rapid Pathogen Screening

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Study Start: 2012-10
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2020-08-13
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Results First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
InflammaDry	InflammaDry	Patients suspected of having dry eye will be tested with the InflammaDry.

Primary Outcome Measures

Name	Time	Method
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes	20 minutes	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.

Trial Locations

Locations (4)

Manatee-Sarasota Eye Clinic; 🇺🇸 Bradenton, Florida, United States

Mercy Clinic - Eye Specialists; 🇺🇸 Springfield, Missouri, United States

Ophthalmic Associates; 🇺🇸 Johnson City, New York, United States

Ophthalmology Diagnostics & Clinical Research; 🇺🇸 El Paso, Texas, United States