Meibomian Gland DysfunctionPhase 4NCT06326931
Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction
A Phase 4 study testing thermal pulsation and warm compress in people with Meibomian Gland Dysfunction, run by Jacksoneye at 1 site in United States.
Trial summary
This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- thermal pulsation and warm compress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2022to 22 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of self-reported dry eye symptoms for 3 months prior to study enrollment
- baseline OSDI score of 23 or greater (
- MGS score of 12 ior less in the lower eyelid of each eye
- TBUT <10 seconds
- willing and able to abstain from using any new ocular lubricants
Who cannot join
- diagnosis of thyroid dysfunction or rheumatoid arthritis
- history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
- abnormal lid anatomy or active lid lesions
- use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
- active ocular infection
- pterygium
- planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops
- CDVA worse than 0.2 logMAR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction
This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.
Read the detailed description
This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).
Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score >23, total meibomian gland secretion (MGS) score < or =12 in the lower lid of each eye, and tear break-up time (TBUT) < 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- thermal pulsation, warm compress
- 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 pulsationDevice
Also called Systane iLux
Single, in-office bilateral treatment with Systane iLux thermal pulsation
warm compressOther
Also called Bruder mask
Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thermal pulsation group | Experimental | Group treated in both eyes with a single Systane iLux thermal pulsation treatment Receives: Device: thermal pulsation |
| Warm compress group | Active comparator | Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks Receives: Other: warm compress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MGS score for the worse eye
Change in MGS score for the worse eye
Measured: baseline to Week 8
Secondary outcomes (4)
Change in MGS score for the worse eye
Change in MGS score for the worse eye
Measured: baseline to Week 2
Change in OSDI score
Change in OSDI score
Measured: Baseline to Week 2
Change in OSDI score
Change in OSDI score
Measured: Baseline to Week 8
Incidence of adverse events
Incidence of adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start24 Jun 2022
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacksoneye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Bollinger, OD, FAAO, Jacksoneye
- Investigators
- Melissa Bollinger, OD, FAAO, Principal investigator, Jacksoneye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326931
- Sponsor's protocol ID
- JE001
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT06326931
- Acronym / sponsor ID
- JE001
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- JacksoneyeUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 22 Mar 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.
This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.
Detailed description
This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).
Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score >23, total meibomian gland secretion (MGS) score < or =12 in the lower lid of each eye, and tear break-up time (TBUT) < 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Thermal pulsation group | Experimental | Device: thermal pulsationGroup treated in both eyes with a single Systane iLux thermal pulsation treatment |
| Warm compress group | Active comparator | Other: warm compressGroup treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- history of self-reported dry eye symptoms for 3 months prior to study enrollment
- baseline OSDI score of 23 or greater (
- MGS score of 12 ior less in the lower eyelid of each eye
- TBUT <10 seconds
- willing and able to abstain from using any new ocular lubricants
Key exclusion criteria (8 listed)
- diagnosis of thyroid dysfunction or rheumatoid arthritis
- history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
- abnormal lid anatomy or active lid lesions
- use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
- active ocular infection
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 pulsationAlso: Systane iLuxSingle, in-office bilateral treatment with Systane iLux thermal pulsation | Device | Thermal pulsation group |
| warm compressAlso: Bruder maskTwice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks | Other | Warm compress group |
Primary outcome
Change in MGS score for the worse eye
Time frame: baseline to Week 8
Change in MGS score for the worse eye
4 secondary outcomes
Change in MGS score for the worse eye
Time frame: baseline to Week 2
Change in OSDI score
Time frame: Baseline to Week 2
Change in OSDI score
Time frame: Baseline to Week 8
Incidence of adverse events
Time frame: 8 weeks
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 22 Mar 2024.
- Individual participant dataSharing planned: No
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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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.
Melissa Bollinger, OD, FAAO principal investigator
Jacksoneye
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 thermal pulsation and warm compress in people with Meibomian Gland Dysfunction, run by Jacksoneye 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 8 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 22 Mar 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.
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 in MGS score for the worse eye (time frame: baseline to Week 8). 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 22 Mar 2024.