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Closed Eye Neutrophils in Dry Eye Disease

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Dry Eye
Ocular Inflammation

Treatments

Other: Eye wash

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03332342
000517538

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

153 participants in 3 patient groups

Daily rinse of ocular surface
Experimental group
Description:
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.
Treatment:
Other: Eye wash
Weekly rinse of ocular surface
Active Comparator group
Description:
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.
Treatment:
Other: Eye wash
Occasional rinse of ocular surface
Experimental group
Description:
Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions
Treatment:
Other: Eye wash

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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