Clinical trial NCT03332342: Closed Eye Neutrophils in Dry Eye Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Ocular Inflammation
Keywords: dry eye disease
tears
inflammation
ocular surface
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Allergan Sales, LLC
First posted: 2017-11-06
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comfort assessment using the dry eye questionnaire
timeFrame: Baseline to 4 weeks
measure: Comfort assessment using the ocular surface disease index
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Repeatability of diagnostic in measuring leukocyte count
timeFrame: Baseline to 4 weeks
measure: Repeatability of diagnostic in measuring leukocyte phenotype
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB School of Optometry
name: Kelly K Nichols, OD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: