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Radiofrequency Device

Forma Eye treatment for Dry Eye Syndrome

N/A
Waitlist Available
Led By Sean Paul, MD
Research Sponsored by InMode MD Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1month, 3 months, 6 months
Awards & highlights

Study Summary

This trial will assess whether a radiofrequency treatment is safe and effective for treating dry eye disease caused by meibomian gland dysfunction.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1month, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Meibomian Gland Score (MGS), as assessed by a masked rater
Change in Tear Break-Up Time
Mean change in Standardized patient Evaluation of Eye Dryness (SPEED)
Secondary outcome measures
Improvement in NEI grading measurements
Mean change in Ocular Surface Disease Index (OSDI)
Safety assessment
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Forma Eye treatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Forma Eye Applicator
2019
N/A
~40

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,330 Total Patients Enrolled
Sean Paul, MDPrincipal Investigator4316 James Casey St Building F Suite 201, Austin, TX 78745, United States
Sandy Zhang-Nunes, MDPrincipal InvestigatorOculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Sean Paul
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
2019. "Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04120584.
~6 spots leftby Apr 2025
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