Dry Eye, Ocular Inflammation
Conditions
Keywords
dry eye disease, tears, inflammation, ocular surface
Brief summary
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
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.
Interventions
OTHEREye wash
Research subjects will perform a wash of their ocular surface with phosphate buffered saline
Sponsors
Allergan Sales, LLC
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort assessment using the dry eye questionnaire | Baseline to 4 weeks | Mean change from baseline in comfort following daily ocular surface washes |
| Comfort assessment using the ocular surface disease index | Baseline to 4 weeks | Mean change from baseline in comfort following daily ocular surface washes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeatability of diagnostic in measuring leukocyte count | Baseline to 4 weeks | Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry |
| Repeatability of diagnostic in measuring leukocyte phenotype | Baseline to 4 weeks | Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry |
Countries
United States
Outcome results
None listed