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

NCT ID: NCT05945069

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-09-05

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TriLift

Combination of Dynamic Muscle Stimulation and Radiofrequency

Group Type: EXPERIMENTAL

TriLift device

Intervention Type: DEVICE

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

Interventions

TriLift device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James G Chelnis, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Face and Eye

Locations

Manhattan Face and Eye Cosmetic and Orbital Surgery

New York, New York, United States

Countries

United States

Other Identifiers

LUM-VBU-TRILIFT-23-01

Identifier Type: -

Identifier Source: org_study_id