Closed Eye Neutrophils in Dry Eye Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Closed Eye Neutrophils on Dry Eye Disease Pathogenesis: Investigation on Repeatability and Effectiveness of an Eye Wash at Awakening for Diagnosis and Therapy

Conditions
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Dry Eye, Ocular Inflammation

Intervention / Treatment
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* Other: Eye wash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to understand and sign an informed consent and HIPAA privacy document greater than 18 years of age at time of informed consent able and willing to follow protocol instructions, including performing at-home washes of the ocular surface and subsequent delivery of those samples to campus on a regular basis must be willing to have blood drawn Exclusion Criteria: contact lens wear within past three months current consumption of cigarettes or tobacco, including e-cigarettes participation in any investigational drug studies within 30 days of informed consent pregnancy, by self-report active ocular infection or inflammation any refractive surgery within the past year any present Accutane (Isotretinoin) use any medication usage that, in the investigator's opinion, could be expected to interfere with the study, such as current use of topical steroids, Restasis, or Xiidra have any uncontrolled systemic disease, that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily rinse of ocular surface<br>Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily. | Other: Eye wash<br>* Research subjects will perform a wash of their ocular surface with phosphate buffered saline<br>|
| Active Comparator: Weekly rinse of ocular surface<br>Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly. | Other: Eye wash<br>* Research subjects will perform a wash of their ocular surface with phosphate buffered saline<br>|
| Experimental: Occasional rinse of ocular surface<br>Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions | Other: Eye wash<br>* Research subjects will perform a wash of their ocular surface with phosphate buffered saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry | Baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye disease, tears, inflammation, ocular surface