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

Not Applicable

Completed

• Conditions: Dry Eye; Skin Laxity; Eyelid Diseases; Eyelid Movement Disorders; Dry Eye Syndromes
• Interventions: Device: TriLift device

• Registration Number: NCT05945069
• Lead Sponsor: Lumenis Be Ltd.

Brief Summary

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 Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-14
• Study Start: 2023-08-01
• Primary Completion: 2024-09-05
• Study Completion: 2024-09-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Any condition revealed whereby the study investigator deems the subject inappropriate for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TriLift	TriLift device	Combination of Dynamic Muscle Stimulation and Radiofrequency

Primary Outcome Measures

Name	Time	Method
Impaired blink quality	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.

Trial Locations

Locations (1)

Manhattan Face and Eye Cosmetic and Orbital Surgery; 🇺🇸 New York, New York, United States