NCT02554084

Brief Summary

The purpose of this study is to evaluate a new instrument that takes digital images of tear film (a thin film that coats the eye that is made up of oil and water). The investigators are interested in measuring how the thickness of the tear film varies through time. The goal is to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future clinical diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

November 24, 2014

Last Update Submit

April 18, 2018

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

  • Thickness of lipid layers on patient cornea (nm)

    Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of lipid-layer thickness.

    participants will be seen once within a one year period, on average within 1 month

  • Thickness of aqueous layers on patient cornea (um)

    Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of aqueous-layer thickness.

    participants will be seen once within a one year period, on average within 1 month

Secondary Outcomes (2)

  • Thickness maps dynamics

    participants will be seen once within a one year period, on average within 1 month

  • Optical aberrations

    participants will be seen once within a one year period, on average within 1 month

Study Arms (2)

Dry Eye Disease

EXPERIMENTAL

Optical Coherence Tomography

Other: Optical Coherence Tomography

Normals

ACTIVE COMPARATOR

Optical Coherence Tomography

Other: Optical Coherence Tomography

Interventions

Optical Coherence TomographyOTHER

Digital images of tear film

Dry Eye DiseaseNormals

Eligibility Criteria

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

You may qualify if:

  • Clinically diagnosed Dry Eye Disease
  • Normal individuals (those without a dry eye diagnosis and without eye abnormalities)
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
  • Ability to give informed consent
  • Willing to spend time for the study
  • Either gender
  • Any racial or ethnic origin

You may not qualify if:

  • Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the study visit
  • Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy
  • Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago
  • Use of soft or hard contact lenses 6 hours prior to visit
  • Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions)
  • Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV) (subjects will be asked to self-report these conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Jannick Rolland, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2014

First Posted

September 18, 2015

Study Start

November 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

US(1)