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OpenTrials
Completed

NCT Number: NCT03332342

Closed Eye Neutrophils in Dry Eye Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye wash

Other

Research subjects will perform a wash of their ocular surface with phosphate buffered saline

Primary outcomes

  1. Comfort assessment using the dry eye questionnaire

    Time frame: Baseline to 4 weeks

    Mean change from baseline in comfort following daily ocular surface washes

  2. Comfort assessment using the ocular surface disease index

    Time frame: Baseline to 4 weeks

    Mean change from baseline in comfort following daily ocular surface washes

Secondary outcomes

  1. Repeatability of diagnostic in measuring leukocyte count

    Time frame: Baseline to 4 weeks

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

  2. Repeatability of diagnostic in measuring leukocyte phenotype

    Time frame: Baseline to 4 weeks

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Allergan Sales, LLC

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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