Closed Eye Neutrophils in Dry Eye Disease

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03332342
• Collaborator: Allergan Sales, LLC (Industry)
• Enrollment: 153
• Location: 1
• Arms: 3
• Actual Duration (Months): 18.1
• Patients Per Site Per Month: 8.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Ocular Inflammation	Other: Eye wash	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Nov 8, 2017
• Actual Primary Completion Date: Dec 12, 2018
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daily rinse of ocular surface Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed daily.	Other: Eye wash; Research subjects will perform a wash of their ocular surface with phosphate buffered saline
Active Comparator: Weekly rinse of ocular surface Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed weekly.	Other: Eye wash; Research subjects will perform a wash of their ocular surface with phosphate buffered saline
Experimental: Occasional rinse of ocular surface Eye wash of the ocular surface with one teaspoon of saline immediately upon awakening, performed on two separate occasions	Other: Eye wash; Research subjects will perform a wash of their ocular surface with phosphate buffered saline

Outcome Measures

Primary Outcome Measures

1. Comfort assessment using the dry eye questionnaire [Baseline to 4 weeks]

   Mean change from baseline in comfort following daily ocular surface washes

2. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Allergan Sales, LLC

Investigators

• Principal Investigator: Kelly K Nichols, OD MPH PhD, UAB School of Optometry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kelly Nichols, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03332342
• Other Study ID Numbers: 000517538
• First Posted: Nov 6, 2017
• Last Update Posted: May 17, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kelly Nichols, Principal Investigator, University of Alabama at Birmingham: dry eye disease; tears; inflammation; ocular surface
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Inflammation

Study Results

No Results Posted as of May 17, 2019