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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.
The premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aqueous Dificiency Dry Eye | 20 Participants | ||
| Meibomian Gland Disease Dry Eye | 20 Participants | ||
| Normal Eye | 20 Participants |
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| Measure | Description | Time Frame |
|---|---|---|
| The measured difference in Tear Osmolarity during the course of the day to support clinical diagnosis and differentiate between aqueous-deficiency and meibomian gland disease. | 1 Day (AM and PM Diurnal) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Improvement | Improvement in Ocular Surface Disease Index, Best Corrected Visual Acuity, Uncorrected Visual Acuity, Slit Lamp Exam, Schirmer test, Lissamine green conjunctival staining, Fluorescein corneal staining and Tear Break Up Time | 31 Days |
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Inclusion Criteria:
Healthy males and females ≥ 18 years old
Negative urine pregnancy results for females of childbearing potential
Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures
Has 20/40 BCVA or better in at least one eye
Does not currently wear contact lenses
For Aqueous-Deficiency Group:
For Meibomian Gland Disease Group:
For Normal Group:
Exclusion Criteria:
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Primary care facility
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| Name | Affiliation | Role |
|---|---|---|
| Eric D Donnenfeld, MD | Ophthalmic Consultants of Long Island | Principal Investigator |
| Barbara Burger, RN | Ophthalmic Consultants of Long Island | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Connecticut | Fairfield | Connecticut | 06824 | United States | ||
| Ophthalmic Consultants of Long Island |
PI will present study outcomes to associates
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Lynbrook |
| New York |
| 11563 |
| United States |
| Ophthalmic Consultants of Long Island | Manhasset | New York | 11030 | United States |
| Ophthalmic Consultants of Long Island | Port Jefferson | New York | 11777 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Ophthalmic Consultants of Long Island | Valley Stream | New York | 11581 | United States |