Dry EyeNCT07579130
Comparative Assessment of Lipid Layer Thickness Measurements
An observational study of Dry Eye, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- LipiView, Omnicad and Bruder Ocular Surface Analyzer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 20 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the clinic with dry eye disease symptoms will be included in the study.
Who may be able to join
- Dry eye disease
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atwater Eye Care Center
Bloomington, Indiana, 47405
Anna Tichenor, 812-855-0520, annatich@iu.edu
Anna Tichenor, OD PhD
About this study
Official title: Comparative Assessment of Lipid Layer Thickness Measurements Across Three Devices and Their Correlation With Clinical Indicators in Dry Eye Disease
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.
- Conditions
- Dry Eye
- Being tested
- LipiView, Omnicad, Bruder Ocular Surface Analyzer
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiViewDevice
Subjects will undergo lipid layer thickness measurement
OmnicadDevice
Subjects will undergo lipid layer thickness measurement
Bruder Ocular Surface AnalyzerDevice
Subjects will undergo lipid layer thickness measurement
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye | Patients with dry eye disease will undergo measurement of lipid layer thickness on all 3 devices in random order. Receives: Device: LipiView; Device: Omnicad; Device: Bruder Ocular Surface Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Layer Thickness
Average and minimum lipid layer thickness measurements will be compared across devices
Measured: measurements taken at single visit, baseline
Secondary outcomes (1)
Correlation with dry eye clinical measurements
Correlations will be compared and analyzed with clinical dry eye measuremetns
Measured: measurements taken at single visit, baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Apr 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Tichenor, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579130
- Sponsor's protocol ID
- 29789
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Lipid Layer Thickness Measurements Across Three Devices and Their Correlation With Clinical Indicators in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07579130
- Acronym / sponsor ID
- 29789
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Eye | – | Device: LipiView, Device: Omnicad, Device: Bruder Ocular Surface AnalyzerPatients with dry eye disease will undergo measurement of lipid layer thickness on all 3 devices in random order. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the clinic with dry eye disease symptoms will be included in the study.
Key inclusion criteria (1 listed)
- Dry eye disease
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipiViewSubjects will undergo lipid layer thickness measurement | Device | Dry Eye |
| OmnicadSubjects will undergo lipid layer thickness measurement | Device | Dry Eye |
| Bruder Ocular Surface AnalyzerSubjects will undergo lipid layer thickness measurement | Device | Dry Eye |
Primary outcome
Lipid Layer Thickness
Time frame: measurements taken at single visit, baseline
Average and minimum lipid layer thickness measurements will be compared across devices
1 secondary outcome
Correlation with dry eye clinical measurements
Time frame: measurements taken at single visit, baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Tichenor (8128550520, annatich@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Layer Thickness (time frame: measurements taken at single visit, baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.