MGD-Meibomian Gland DysfunctionReduceNCT06542276
Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
A study testing Thermal Vectored Pulsation in people with MGD-Meibomian Gland Dysfunction, run by Dunes Eye Consultants at 1 site in United States.
Trial summary
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MGD-Meibomian Gland Dysfunction
- What is being tested?
- Thermal Vectored Pulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
- lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
- Meibograpy documneted retention of at least 50% of meibomian glands.
Who cannot join
- evidence of meibomian gland dropout exceeding 50%
- ocular rosacea,
- ocular surgery within the preceding three months
- prior in-office thermal meibomian gland treatment
- ocular trauma within preceding three months
- ocular herpetic infection
Show all 9Show fewer
- chronic or recurrent inflammation
- eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Dunes Eye Consultants
Dakota Dunes, South Dakota, 57049
About this study
Official title: Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
Read the detailed description
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.
- Conditions
- MGD-Meibomian Gland Dysfunction
- Being tested
- Thermal Vectored Pulsation
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Vectored PulsationDevice
Also called Lipiflow
The LipiFlow® (Johnson \& Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents.
| Study group | Role | What they receive |
|---|---|---|
| Lipiflow treatment results | Other | A single thermal vectored pulsation treatment of MGD with 3 month results review of treatment to evaluate objective and subjective response. Receives: Device: Thermal Vectored Pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects discontinuing Topical Immunomodulator use
OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2023
- Primary completion28 Feb 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MGD-Meibomian Gland DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dunes Eye Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Steve Ferguson, Dunes Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542276
- Sponsor's protocol ID
- DunesEye
- Acronym
- Reduce
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Abstract
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06542276
- Acronym / sponsor ID
- Reduce / DunesEye
- Conditions
- MGD-Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dunes Eye ConsultantsUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 Aug 2024 (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.
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
Detailed description
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study, known as the REDUCE study, was a prospective, non-randomized, single-site, non- comparative study that evaluated the efficacy of a single vectored thermal pulsation (VTP) treatment in patients who were currently being treated with topical immunomodulator agents. This study was conducted in compliance with the Declaration of Helsinski and was reviewed and approved by the WCG institutional review board (IRB). The study is registered in clinictrials.gov. All participants provided written informed consent.
| Arm | Type | Receives |
|---|---|---|
| Lipiflow treatment results | Other | Device: Thermal Vectored PulsationA single thermal vectored pulsation treatment of MGD with 3 month results review of treatment to evaluate objective and subjective response. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
- lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
- Meibograpy documneted retention of at least 50% of meibomian glands.
Key exclusion criteria (9 listed)
- evidence of meibomian gland dropout exceeding 50%
- ocular rosacea,
- ocular surgery within the preceding three months
- prior in-office thermal meibomian gland treatment
- ocular trauma within preceding three months
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 |
|---|---|---|
| Thermal Vectored PulsationAlso: LipiflowThe LipiFlow® (Johnson \& Johnson Vision, USA) Thermal Pulsation System, also known as vectored thermal pulsation, is a treatment that applies localized heat and pressure to the meibomian glands lining the eyelids. The device consists of a console connected to single-use, sterile devices applied to each eye known as activators. The activator includes an eye warmer with a large lens that gently sits on the conjunctiva of each eye. The activator cups the upper and lower eyelid and applies regulated, outward heat to the surface of the palpebral conjunctiva with an air bladder that intermittently provides directional, controlled massage of the eyelids to promote expression of the liquified contents. | Device | Lipiflow treatment results |
Primary outcome
Number of Subjects discontinuing Topical Immunomodulator use
Time frame: 3 months
OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. Abstract
Related trials for MGD-Meibomian Gland Dysfunction
Not yet recruiting
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Vectored Pulsation in people with MGD-Meibomian Gland Dysfunction, run by Dunes Eye Consultants 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 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
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?
Number of Subjects discontinuing Topical Immunomodulator use (time frame: 3 months). 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 12 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.