NCT04120584

Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for dry eye disease due to meibomian gland dysfunction

Conditions

• Improvement of Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Forma Eye Applicator	Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.

Timeline

• Start date: 2019-10-22
• Primary completion: 2022-07-25
• Completion: 2022-07-25
• First posted: 2019-10-09
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study