Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease

NCT05945069 | Completed FDA Device

• 1 other identifier: LUM-VBU-TRILIFT-23-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease

Conditions

Eyelid Diseases; Eyelid Movement Disorders; Dry Eye; Dry Eye Syndromes; Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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.

  7 weeks after baseline (4 weeks after the 4th treatment)

Other Outcomes (12)

• Eyelid appearance

  7 weeks after baseline (4 weeks after the 4th treatment)

• Overall blink quality

  7 weeks after baseline (4 weeks after the 4th treatment)

• Margin to Reflex Distances MRD1 and MRD2

  7 weeks after baseline (4 weeks after the 4th treatment)

Study Arms (1)

TriLift

EXPERIMENTAL

Combination of Dynamic Muscle Stimulation and Radiofrequency

Device: TriLift device

Interventions

TriLift device DEVICE

Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids

TriLift

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to read, understand and sign an Informed Consent Form (ICF)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Manhattan Face and Eye Cosmetic and Orbital Surgery

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Eyelid Diseases; Dry Eye Syndromes; Cutis Laxa

Condition Hierarchy (Ancestors)

Eye Diseases; Lacrimal Apparatus Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• James G Chelnis, MD

  Manhattan Face and Eye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 14, 2023
• Study Start: August 1, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)