Eyelid DiseasesNCT05945069
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease
A study testing TriLift device in people with Eyelid Diseases and Eyelid Movement Disorders, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Eyelid Diseases, Eyelid Movement Disorders, Dry Eye
- What is being tested?
- TriLift device
- 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 Aug 2023to 5 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand and sign an Informed Consent Form (ICF)
- 22 or older
- Lower lid laxity, as clinically judged with lower lid DT and the snapback test
- Moderate to severe OSDI (larger or equal to 23)
- TBUT smaller or equal to 5 sec in both eyes
Who cannot join
- Abnormally high blink rate, as estimated by the study investigator
- Any ocular surgery or eyelid surgery, within 3 months prior to screening
- Blepharoptosis
- Moderate or Severe Floppy Lid Syndrome
- Corneal Dystrophy
- Exophthalmos
Show all 16Show fewer
- Thyroid Eye Disease
- Ocular Chemical Injury or burn
- Limbal Stem Cell Deficiency
- Facial Nerve Palsy
- Blepharospasm
- Hemifacial Spasm
- Corneal neuropathy
- Pregnant or nursing women
- Participation in a different study
- Any condition revealed whereby the study investigator deems the subject inappropriate for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Face and Eye Cosmetic and Orbital Surgery
New York, New York, 10019
About this study
Official title: Feasibility of Dynamic Muscle Stimulation (DMSt) Combined with Radiofrequency (RF) for Improving Blink Quality in Subjects with Dry Eye Disease (DED)
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
Read the detailed description
The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.
- Being tested
- TriLift device
- Medical subject headings
- Eyelid Diseases, Dry Eye Syndromes, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriLift deviceDevice
Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids
| Study group | Role | What they receive |
|---|---|---|
| TriLift | Experimental | Combination of Dynamic Muscle Stimulation and Radiofrequency Receives: Device: TriLift device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impaired blink quality
binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision.
Measured: 7 weeks after baseline (4 weeks after the 4th treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James G Chelnis, MD, Principal investigator, Manhattan Face and Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945069
- Sponsor's protocol ID
- LUM-VBU-TRILIFT-23-01
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dynamic Muscle Stimulation (DMSt) Combined with Radiofrequency (RF) for Improving Blink Quality in Subjects with Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT05945069
- Acronym / sponsor ID
- LUM-VBU-TRILIFT-23-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 14 Jul 2023 (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 demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
Detailed description
The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TriLift | Experimental | Device: TriLift deviceCombination of Dynamic Muscle Stimulation and Radiofrequency |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is able to read, understand and sign an Informed Consent Form (ICF)
- 22 or older
- Lower lid laxity, as clinically judged with lower lid DT and the snapback test
- Moderate to severe OSDI (larger or equal to 23)
- TBUT smaller or equal to 5 sec in both eyes
Key exclusion criteria (16 listed)
- Abnormally high blink rate, as estimated by the study investigator
- Any ocular surgery or eyelid surgery, within 3 months prior to screening
- Blepharoptosis
- Moderate or Severe Floppy Lid Syndrome
- Corneal Dystrophy
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 |
|---|---|---|
| TriLift deviceDynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids | Device | TriLift |
Primary outcome
Impaired blink quality
Time frame: 7 weeks after baseline (4 weeks after the 4th treatment)
binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision.
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 10 Mar 2025.
- Individual participant dataSharing planned: No
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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.
James G Chelnis, MD principal investigator
Manhattan Face and Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriLift device in people with Eyelid Diseases and Eyelid Movement Disorders, run by Lumenis Be Ltd. 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 16 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 10 Mar 2025. 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?
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?
Impaired blink quality (time frame: 7 weeks after baseline (4 weeks after the 4th treatment)). 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 10 Mar 2025.