NCT03332342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

October 25, 2017

Last Update Submit

May 15, 2019

Conditions

Dry EyeOcular Inflammation

Keywords

dry eye diseasetearsinflammationocular surface

Outcome Measures

Primary Outcomes (2)

  • Comfort assessment using the dry eye questionnaire

    Mean change from baseline in comfort following daily ocular surface washes

    Baseline to 4 weeks

  • Comfort assessment using the ocular surface disease index

    Mean change from baseline in comfort following daily ocular surface washes

    Baseline to 4 weeks

Secondary Outcomes (2)

  • Repeatability of diagnostic in measuring leukocyte count

    Baseline to 4 weeks

  • Repeatability of diagnostic in measuring leukocyte phenotype

    Baseline to 4 weeks

Study Arms (3)

Daily rinse of ocular surface

EXPERIMENTAL

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

Other: Eye wash

Weekly rinse of ocular surface

ACTIVE COMPARATOR

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

Other: Eye wash

Occasional rinse of ocular surface

EXPERIMENTAL

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

Other: Eye wash

Interventions

Eye washOTHER

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

Daily rinse of ocular surfaceOccasional rinse of ocular surfaceWeekly rinse of ocular surface

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesLacerationsInflammation

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly K Nichols, OD MPH PhD

    UAB School of Optometry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 6, 2017

Study Start

November 8, 2017

Primary Completion

December 12, 2018

Study Completion

May 14, 2019

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)