NCT05945069

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	TriLift device	Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2023-07-14
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study