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| Name | Class |
|---|---|
| Allergan Sales, LLC | INDUSTRY |
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The purpose of this prospective study is to evaluate different inflammatory cells that accumulate on the ocular surface, during sleep, and how these cells may contribute to dry eye disease. This study will involve at-home self-collection of tears using an eye wash method with sterile saline solution. While a diagnostic technique, the eye wash may also have a therapeutic benefit in dry eye sufferers, which will be assessed in the second phase of this project.
Every night during sleep, there is an influx of white blood cells on to the surface of the eye. These cells likely perform a protective function, but it is also possible that their dysregulation could lead to disease. Using a larger cohort, our investigation hopes to better understand the function of these cells and their potential to be linked to dry eye disease. Further, the way in which these cells are collected, using an at-home self-collection of tears using an eye wash method with sterile saline solution, immediately upon awakening, could potentially provide relief to dry eye sufferers if performed on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily rinse of ocular surface | Experimental | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily. |
|
| Weekly rinse of ocular surface | Active Comparator | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly. |
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| Occasional rinse of ocular surface | Experimental | Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye wash | Other | Research subjects will perform a wash of their ocular surface with phosphate buffered saline |
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| Measure | Description | Time Frame |
|---|---|---|
| Comfort assessment using the dry eye questionnaire | Mean change from baseline in comfort following daily ocular surface washes | Baseline to 4 weeks |
| Comfort assessment using the ocular surface disease index | Mean change from baseline in comfort following daily ocular surface washes | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of diagnostic in measuring leukocyte count | Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry | Baseline to 4 weeks |
| Repeatability of diagnostic in measuring leukocyte phenotype |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly K Nichols, OD MPH PhD | UAB School of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D022125 | Lacerations |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
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Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry
| Baseline to 4 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |