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Trial record 2 of 42 for:    forma

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

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ClinicalTrials.gov Identifier: NCT04120584
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date January 10, 2020
Actual Study Start Date  ICMJE October 22, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Mean change in Standardized patient Evaluation of Eye Dryness (SPEED) [ Time Frame: 1month, 3 months, 6 months ]
    Mean change from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in Standardized Patient Evaluation of Eye Dryness (SPEED)
  • Mean change in Ocular Surface Disease Index (OSDI) [ Time Frame: 1 Month, 3 months, 6 months ]
    Mean change from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in Ocular Surface Disease Index (OSDI)
  • Improvement in NEI grading measurements [ Time Frame: 1 month, 3 months, 6 months ]
    Improvement measurements using ocular surface fluorescent staining. NEI grading scheme grading for ocular surface staining score will be used in this study.
  • Change in Meibomian Gland Score (MGS), as assessed by a masked rater [ Time Frame: 1 month, 3 months, 6 months ]
    Changes from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in in Meibomian Gland Score (MGS), as assessed by a masked rater, and Tear Break-Up Time (TBUT).
  • Change in Tear Break-Up Time [ Time Frame: 1 month, 3 months, 6 months ]
    Changes from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) assessed by Tear Break-up time (TBUT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Subject's assessment of improvement [ Time Frame: 1 month, 3 months, 6 months ]
    Subject assessment of improvement based on 0 - 4-point Likert scale at four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) follow up visits. Improvement assessment will be performed independently by the subject himself on the following 0-4 points Likert scale questionnaire (Global Aesthetic Improvement Scale): 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference
  • Subject assessment of satisfaction [ Time Frame: 1 month, 3 months, 6 months ]
    Subject assessment of satisfaction will be filled-out by subjects only using 5-points Likert scale at four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) follow up visits: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed
  • Safety assessment [ Time Frame: 1 month, 3 months, 6 months ]
    The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)
  • Safety assessment [ Time Frame: 2 weeks, 4 weeks and 6 weeks ]
    Discomfort assessment during the treatment using NSR scale. At each treatment the subject will be asked to fill assessments for the pain/discomfort during the procedure. The subject will be asked to rate the severity from 0 to 10, with 0 equaling no symptoms and 10 equaling the worst possible symptoms. A number is obtained by measuring up to the point the subject has indicated
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Official Title  ICMJE Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Improvement of Dry Eye Disease
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Forma Eye treatment
Intervention: Device: Forma Eye Applicator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult females and males between the ages of 18 -75, seeking treatments for Dry Eye Disease Due to Meibomian Gland Dysfunction
  2. Tear breakup time (TBUT) ≤10 s;
  3. Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
  4. Subjective symptom score (using the Standard Patient Evaluation of Eye Dryness [SPEED] questionnaire) ≥10;
  5. At least one meibomian gland opening with a visible plugging over the eyelid margin
  6. No ocular pathology requiring treatment other than eye lubricant and conventional eyelid hygiene within the last month and during the study
  7. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form
  8. The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
  9. Agreement/ability to abstain from dry eye/MGD medications or any device treatments for the time between the treatment visit and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion Criteria:

  1. Evidence of co-existing ocular conditions potentially posing an increased risk of procedure-related injury, (e.g., active ocular infection or inflammation in either eye)
  2. History of ocular trauma or surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year
  3. Ocular surface abnormality potentially compromising corneal integrity in either eye; eyelid abnormalities affecting lid function in either eye
  4. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
  5. Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
  6. Individuals who have either changed the dosing of systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to screening
  7. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
  8. Permanent metal implant in the treatment area
  9. Any surgery in the treatment area in the last 3 months
  10. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
  11. Pregnancy and nursing or females of childbearing potential and not utilizing adequate birth control measures
  12. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
  13. Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
  14. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary, and hormonal virilization
  15. Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes, and rash.
  16. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
  17. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
  18. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
  19. Participation in another study within 30 days prior to screening.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maureen Abdulla 949.305.0106 maureen.abdulla@inmodemd.com
Contact: Maria Shusterman 4164589001 marias@inmodemd.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04120584
Other Study ID Numbers  ICMJE DO609175A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InMode MD Ltd.
Study Sponsor  ICMJE InMode MD Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Paul, MD 4316 James Casey St Building F Suite 201, Austin, TX 78745, United States
Principal Investigator: Sandy Zhang-Nunes, MD Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine
PRS Account InMode MD Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP