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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Dry Eye Syndromes; Eyelid Diseases; Skin Laxity; Eyelid Movement Disorders
• Intervention / Treatment: Device: TriLift device

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yair Manor, Ph.D.; Phone Number: +972-52-376-3416; Email: yair.manor@lumenis.com
• Study Contact Backup: Name: James G Chelnis, MD; Phone Number: (+1) 212-484-9707; Email: drchelnis@manhattanfaceandeye.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • Manhattan Face and Eye Cosmetic and Orbital Surgery
      • Contact: James Chelnis, MD; Phone Number: 212-484-9707; Email: drchelnis@manhattanfaceandeye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TriLift; Combination of Dynamic Muscle Stimulation and Radiofrequency	Device: TriLift device; Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyelid appearance	Biomicroscopy with the slit lamp; normal, mild, moderate, severe	7 weeks after baseline (4 weeks after the 4th treatment)
Overall blink quality	Subjectively assessed by the study investigator; normal, mildly impaired, moderately impaired, severely impaired	7 weeks after baseline (4 weeks after the 4th treatment)
Margin to Reflex Distances MRD1 and MRD2	Distances from the margins of the upper and lower lids to the central corneal reflex, in millimeters	7 weeks after baseline (4 weeks after the 4th treatment)
modified Meibomian Gland Score	15 meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modiified Meibomian Gland Score means that the functionality of meibomian glands improved, and that the condition of the patient improved.	7 weeks after baseline (4 weeks after the 4th treatment)
Ocular Surface Disease Index	Symptoms will be self-evaluated with the Ocular Surface Disease Index questionnaire. Twelve (12) questions will be asked about visual difficulties experienced by the subject during the past week. Each question will be scored 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) or 4 (all the time). The Ocular Surface Disease Index will be calculated as the sum of scores times 25, divided by the number of questions answered. An increase in the Ocular Surface Disease Index means that the symptoms are reduced and that the condition of the patient improved.	7 weeks after baseline (4 weeks after the 4th treatment)
Corneal sensitivity	Measured with an esthesiometer; device settings: 1 to 6	7 weeks after baseline (4 weeks after the 4th treatment)
Blink rate	Blinks per minute during a video-watching task	7 weeks after baseline (4 weeks after the 4th treatment)
Degree of eyelid closure	full, or maximal vertical height of the palpebral fissure measured in mm	7 weeks after baseline (4 weeks after the 4th treatment)
Teat Breakup time	Time between full blink and first appearance of a break in a fluorescein-stained eye	7 weeks after baseline (4 weeks after the 4th treatment)
Adverse events	Incidence and type of adverse events	Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment)
BCVA	Best-corrected visual acuity, using an ETDRS chart (20/20, 20/25, 20/32,20/40,20/50,20/63, 20/80, 20/100, 20/200, 20/400, where 20/20 is considered perfect vision and 20/400 is considered legal blindness)	At baseline, at 1 week after baseline (immediately before the second treatment), at 2 weeks after baseline (immediately before the third treatment), at 3 weeks after baseline (immediately before the fourth treatment) and at 7 weeks after baseline
Pain/Discomfort	Pain.discomfort will be self-reported with a visual analog scale (0 to 100), with 0 representing no pain/discomfort and 100 representing intolerable pain/discomfort. A decrease in this visual analog score represents an improvement in the perception of pain/discomfort.	Immediately after a treatment session

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: James G Chelnis, MD, Manhattan Face and Eye

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Movement Disorders; Eyelid Diseases
• Other Study ID Numbers: LUM-VBU-TRILIFT-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No