Closed Eye Neutrophils in Dry Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Inflammation; Dry Eye
• Intervention / Treatment: Other: Eye wash

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Allergan Sales, LLC
• Investigators: Principal Investigator: Kelly K Nichols, OD MPH PhD, UAB School of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: inflammation; ocular surface; tears; dry eye disease
• Additional Relevant MeSH Terms: Pathologic Processes; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Inflammation; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 000517538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No