Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

October 18, 2026 updated by: Eye Surgeons of Indiana

Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.

After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46040
        • Eye Surgeons of Indiana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  • 18 years of age or older
  • Evaporative DED with MGD and clinically significant inflammation
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Altered nasolacrimal flow of either acquired, induced, or congenital origin
  • Hypersensitivity to dexamethasone
  • Patient being treated with either topical, oral, or intravenous steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lipiflow Only Group

Patients with dry eye disease Lipiflow only
Procedure: LipiFlow Thermal Pulsation

To manage patients with dry eye disease secondary to MGD
Experimental: Lipiflow + Dextenza Group

Patients with dry eye disease Lipiflow + Dextenza
Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation

Other Names:
  • Dextenza

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12

Meibomian gland expressibility was graded at the slit lamp using the methodology of the pivotal LipiFlow trial. Fifteen glands of the lower eyelid (5 temporal, 5 central, 5 nasal) were each graded on a 0-3 scale (0 = no secretion; 1 = inspissated/toothpaste-like secretion; 2 = cloudy liquid secretion; 3 = clear liquid secretion). Grades were summed to produce a composite Meibomian Gland Expressibility Score ranging from 0 to 45. Higher scores indicate better meibomian gland function. Values shown are the mean score at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12
Patient Preference
Time Frame: Assessed at Week 12

As measured by COMTOL Survey
Assessed at Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Rate of Positive MMP-9
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Meibomian gland inflammation was assessed using the InflammaDry point-of-care immunoassay, which detects elevated matrix metalloproteinase-9 (MMP-9) levels in tear fluid. Results are reported as positive or negative based on a predefined assay threshold. The outcome represents the proportion of eyes testing positive for MMP-9 at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean Change in Ocular Surface Staining
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Corneal fluorescein staining was graded on a 0-3 scale (none to heavy) in 5 corneal regions (superior, inferior, nasal, temporal, central) and summed for a corneal score (range 0-15). Conjunctival lissamine green staining was graded on the same 0-3 scale in 6 conjunctival regions (3 nasal, 3 temporal) and summed for a conjunctival score (range 0-18). Corneal and conjunctival scores were summed to produce a total Ocular Surface Staining Score ranging from 0 to 33. Higher scores indicate greater ocular surface damage (worse outcome). Values shown are the mean score at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean Change in Tear Break-up Time (TBUT)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Tear break-up time (TBUT) was measured in seconds following fluorescein instillation as the interval between a complete blink and the first appearance of tear film disruption. Higher TBUT values indicate greater tear film stability. Values shown are the mean TBUT at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean Change in Tear Osmolarity (mOsm/L)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Tear osmolarity was measured using a point-of-care tear osmolarity system and reported in milliosmoles per liter (mOsm/L). Higher values indicate greater tear film hyperosmolarity and ocular surface stress. Values shown are the mean tear osmolarity at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean Change in DEQ-5
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Dry eye symptoms were assessed using the Dry Eye Questionnaire-5 (DEQ-5), a validated patient-reported outcome instrument with scores ranging from 0 to 22. Higher DEQ-5 scores indicate greater severity of dry eye symptoms. The outcome represents the mean change in DEQ-5 score from baseline at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean Change in Best-corrected Visual Acuity (BCVA)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and recorded as the number of letters read correctly (range 0 to 100 letters). Higher letter scores indicate better visual acuity. Values shown are the mean BCVA letter score at each study visit.
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eye Surgeons of Indiana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ocular Therapeutix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The DIERKER Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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