Clinical trial: Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction (NCT04120584)

Eligibility criteria:
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.

             -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Contradiction