Closed Eye Neutrophils in Dry Eye Disease

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332342
• Other study ID #: 000517538
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: May 14, 2019

Study information

• Verified date: May 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 14, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Inflammation
• Keratoconjunctivitis Sicca
• Ocular Inflammation

Intervention

Other:
• Eye wash
Research subjects will perform a wash of their ocular surface with phosphate buffered saline

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Allergan Sales, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort assessment using the dry eye questionnaire	Mean change from baseline in comfort following daily ocular surface washes	Baseline to 4 weeks
Primary	Comfort assessment using the ocular surface disease index	Mean change from baseline in comfort following daily ocular surface washes	Baseline to 4 weeks
Secondary	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
Secondary	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