NCT07579130

Brief Summary

This study compares ocular lipid layer thickness (LLT) measurements obtained from three commonly used clinical diagnostic devices to evaluate their agreement and consistency. It further examines which device's LLT measurements show the strongest correlation with established clinical indicators of dry eye disease severity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress8%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Lipid Layer Thickness

    Average and minimum lipid layer thickness measurements will be compared across devices

    measurements taken at single visit, baseline

Secondary Outcomes (1)

  • Correlation with dry eye clinical measurements

    measurements taken at single visit, baseline

Study Arms (1)

Dry Eye

Patients with dry eye disease will undergo measurement of lipid layer thickness on all 3 devices in random order.

Device: LipiViewDevice: OmnicadDevice: Bruder Ocular Surface Analyzer

Interventions

OmnicadDEVICE

Subjects will undergo lipid layer thickness measurement

Dry Eye
LipiViewDEVICE

Subjects will undergo lipid layer thickness measurement

Dry Eye
Bruder Ocular Surface AnalyzerDEVICE

Subjects will undergo lipid layer thickness measurement

Dry Eye

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the clinic with dry eye disease symptoms will be included in the study.

You may qualify if:

  • Dry eye disease

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atwater Eye Care Center

Bloomington, Indiana, 47405, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Anna Tichenor

CONTACT

8128550520annatich@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 11, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 20, 2028

Study Completion (Estimated)

December 20, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations

US(1)