Meibomian Gland DysfunctionNCT04229888
Meibomian Gland Dysfunction Treatment
A study testing LipiFlow in people with Meibomian Gland Dysfunction and Dry Eye, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye
- What is being tested?
- LipiFlow
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- evidence of meibomian gland obstruction in both eyes
- dry eye symptoms per DEQ-5
Who cannot join
- active ocular infection
- previous LipiFlow treatment
- beginning new oral or other systemic medications within prior 3 months
- beginning new or changing dosages of ocular medications within prior 3 months
- previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
- habitual contact lens wear in prior 3 months
- women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Optometry
Bloomington, Indiana, 47405
About this study
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Being tested
- LipiFlow, Light Based (Sham) Treatment
- Keywords
- dry eye, meibomian gland dysfunction, lipiflow
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiFlowDevice
Also called Johnson & Johnson
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Light Based (Sham) TreatmentDevice
A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.
| Study group | Role | What they receive |
|---|---|---|
| Subject Treatment | Experimental | All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. Receives: Device: LipiFlow; Device: Light Based (Sham) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye Questionnaire 5 (DEQ-5) Score
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
Measured: 2 weeks
Secondary outcomes (2)
Meibomian Gland Score
Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)
Measured: 2 weeks
Tear Break-Up Time (TBUT)
Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Feb 2020
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- NCT04229888
- Sponsor's protocol ID
- 1908329543
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2020
- Last updated
- 29 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibomian Gland Dysfunction Treatment
- ClinicalTrials.gov ID
- NCT04229888
- Acronym / sponsor ID
- 1908329543
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Keywords
- dry eye, meibomian gland dysfunction, lipiflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 29 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
| Arm | Type | Receives |
|---|---|---|
| Subject Treatment | Experimental | Device: LipiFlow, Device: Light Based (Sham) TreatmentAll subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- evidence of meibomian gland obstruction in both eyes
- dry eye symptoms per DEQ-5
Key exclusion criteria (7 listed)
- active ocular infection
- previous LipiFlow treatment
- beginning new oral or other systemic medications within prior 3 months
- beginning new or changing dosages of ocular medications within prior 3 months
- previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 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 |
|---|---|---|
| LipiFlowAlso: Johnson & JohnsonMedical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content | Device | Subject Treatment |
| Light Based (Sham) TreatmentA light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment. | Device | Subject Treatment |
Primary outcome
Dry Eye Questionnaire 5 (DEQ-5) Score
Time frame: 2 weeks
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
2 secondary outcomes
Meibomian Gland Score
Time frame: 2 weeks
Tear Break-Up Time (TBUT)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
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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.
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 LipiFlow in people with Meibomian Gland Dysfunction and 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 2 inclusion and 7 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 29 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dry Eye Questionnaire 5 (DEQ-5) Score (time frame: 2 weeks). 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 29 Mar 2022.