Dry Eye SyndromesPhase 4NCT04413279
Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease
A Phase 4 study testing LipiFlow Thermal Pulsation and Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation in people with Dry Eye Syndromes, run by Eye Surgeons of Indiana at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- LipiFlow Thermal Pulsation and Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Surgeons of Indiana
Indianapolis, Indiana, 46040
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- LipiFlow Thermal Pulsation, Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation
- 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.
LipiFlow Thermal PulsationProcedure or surgery
To manage patients with dry eye disease secondary to MGD
Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal PulsationDrug
Also called Dextenza
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
| Study group | Role | What they receive |
|---|---|---|
| Lipiflow Only Group | Active comparator | Patients with dry eye disease Lipiflow only Receives: Procedure: LipiFlow Thermal Pulsation |
| Lipiflow + Dextenza Group | Experimental | Patients with dry eye disease Lipiflow + Dextenza Receives: Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in meibomian gland scores (expressibility and quality)
As measured on a grading scale 1 to 4 and graded by the physician
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12
Patient preference for
As measured by COMTOL Survey
Measured: Assessed at Week 12
Secondary outcomes (6)
Mean change in MMP-9
As measured by InflammaDry
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in ocular surface staining
As measured by sodium fluorescein and lissamine green
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear break-up time (TBUT)
As measured by TBUT testing
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear osmolarity
As measured by TearLab
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in DEQ-5
As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms.
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in Best-corrected Visual Acuity (BCVA)
As measured by ETDRS chart
Measured: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Aug 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Surgeons of Indiana
- Sponsor type
- Research network
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Damon Dierker, OD, FAAO, Principal investigator, Eye Surgeons of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413279
- Sponsor's protocol ID
- The DIERKER Study
- Status last verified
- Apr 2022
- First submitted
- 28 May 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04413279
- Acronym / sponsor ID
- The DIERKER Study
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eye Surgeons of IndianaResearch network
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 2 Jun 2020 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipiflow Only Group | Active comparator | Procedure: LipiFlow Thermal PulsationPatients with dry eye disease Lipiflow only |
| Lipiflow + Dextenza Group | Experimental | Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal PulsationPatients with dry eye disease Lipiflow + Dextenza |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| LipiFlow Thermal PulsationTo manage patients with dry eye disease secondary to MGD | Procedure or surgery | Lipiflow Only Group |
| Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal PulsationAlso: Dextenzato 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 | Drug | Lipiflow + Dextenza Group |
Primary outcome
Change from baseline in meibomian gland scores (expressibility and quality)
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12
As measured on a grading scale 1 to 4 and graded by the physician
Patient preference for
Time frame: Assessed at Week 12
As measured by COMTOL Survey
6 secondary outcomes
Mean change in MMP-9
Time frame: 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
Mean change in tear break-up time (TBUT)
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear osmolarity
Time frame: 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
Mean change in Best-corrected Visual Acuity (BCVA)
Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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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. This study is not recruiting at the moment.
Damon Dierker, OD, FAAO principal investigator
Eye Surgeons of Indiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LipiFlow Thermal Pulsation and Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation in people with Dry Eye Syndromes, run by Eye Surgeons of Indiana 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Apr 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in meibomian gland scores (expressibility and quality) (time frame: Assessed at Baseline, Week 1, Week 4 and Week 12). The study lists 2 primary outcomes in all. 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 18 Apr 2022.