Closed Eye Neutrophils in Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye; Ocular Inflammation
• Interventions: Other: Eye wash

• Registration Number: NCT03332342
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-11-08
• Primary Completion: 2018-12-12
• Status Verified: 2019-05
• Study Completion: 2019-05-14
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily rinse of ocular surface	Eye wash	Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.
Weekly rinse of ocular surface	Eye wash	Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.
Occasional rinse of ocular surface	Eye wash	Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States