Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

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

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Detailed Description

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

Conditions

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Dysfunctional Tear Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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InflammaDry

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

InflammaDry

Intervention Type DEVICE

A noninvasive immunoassay for detecting MMP-9 levels in tears.

Interventions

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InflammaDry

A noninvasive immunoassay for detecting MMP-9 levels in tears.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes