Clinical trial NCT05945069: Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease
Official title: Feasibility of Dynamic Muscle Stimulation (DMSt) Combined with Radiofrequency (RF) for Improving Blink Quality in Subjects with Dry Eye Disease (DED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Diseases
Eyelid Movement Disorders
Dry Eye
Dry Eye Syndromes
Skin Laxity
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Impaired blink quality
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
Secondary outcomes:
Other outcomes:
measure: Eyelid appearance
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Overall blink quality
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Margin to Reflex Distances MRD1 and MRD2
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: modified Meibomian Gland Score
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Ocular Surface Disease Index
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Corneal sensitivity
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Blink rate
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Degree of eyelid closure
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Teat Breakup time
timeFrame: 7 weeks after baseline (4 weeks after the 4th treatment)
measure: Adverse events
timeFrame: Throughout the study and up to 7 weeks after baseline (4 weeks after the 4th treatment)
measure: BCVA
timeFrame: 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
measure: Pain/Discomfort
timeFrame: Immediately after a treatment session
Locations:
city: New York
country: United States
facility: Manhattan Face and Eye Cosmetic and Orbital Surgery
state: New York
Study officials:
affiliation: Manhattan Face and Eye
name: James G Chelnis, MD
role: PRINCIPAL_INVESTIGATOR
References: