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Closed Eye Neutrophils in Dry Eye Disease

Primary Purpose

Dry Eye, Ocular Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eye wash
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye focused on measuring dry eye disease, tears, inflammation, ocular surface

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Daily rinse of ocular surface

Weekly rinse of ocular surface

Occasional rinse of ocular surface

Arm Description

Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.

Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.

Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions

Outcomes

Primary Outcome Measures

Comfort assessment using the dry eye questionnaire
Mean change from baseline in comfort following daily ocular surface washes
Comfort assessment using the ocular surface disease index
Mean change from baseline in comfort following daily ocular surface washes

Secondary Outcome Measures

Repeatability of diagnostic in measuring leukocyte count
Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry
Repeatability of diagnostic in measuring leukocyte phenotype
Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry

Full Information

First Posted
October 25, 2017
Last Updated
May 15, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Allergan Sales, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03332342
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Allergan Sales, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Ocular Inflammation
Keywords
dry eye disease, tears, inflammation, ocular surface

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily rinse of ocular surface
Arm Type
Experimental
Arm Description
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.
Arm Title
Weekly rinse of ocular surface
Arm Type
Active Comparator
Arm Description
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.
Arm Title
Occasional rinse of ocular surface
Arm Type
Experimental
Arm Description
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions
Intervention Type
Other
Intervention Name(s)
Eye wash
Intervention Description
Research subjects will perform a wash of their ocular surface with phosphate buffered saline
Primary Outcome Measure Information:
Title
Comfort assessment using the dry eye questionnaire
Description
Mean change from baseline in comfort following daily ocular surface washes
Time Frame
Baseline to 4 weeks
Title
Comfort assessment using the ocular surface disease index
Description
Mean change from baseline in comfort following daily ocular surface washes
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Repeatability of diagnostic in measuring leukocyte count
Description
Repeatability of the eye wash in terms of leukocyte count, as measured by flow cytometry
Time Frame
Baseline to 4 weeks
Title
Repeatability of diagnostic in measuring leukocyte phenotype
Description
Repeatability of the eye wash in terms of leukocyte phenotype, as measured by flow cytometry
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Nichols, OD MPH PhD
Organizational Affiliation
UAB School of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Closed Eye Neutrophils in Dry Eye Disease

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