Study terminated due to safety assessment of the study product

This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of external and internal eyelid temperature after treatment with the MiBo ThermoFlo.

Inclusion Criteria:

• Potential subjects must satisfy all the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

  3. Between 18 and 80 (inclusive) years of age at the time of screening.

  4. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

     Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breastfeeding.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with participation in the study.
  3. Clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection).
  4. Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading scale.
  5. Any active Ocular Infection or Inflammation
  6. Any history of eyelid surgery or abnormality
  7. History of Metal Implants in the Eyelids
  8. Any known hypersensitivity or allergic reaction to ultrasound coupling gel.
  9. LASIK Surgery within 2 weeks of the Baseline Visit.
  10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  11. History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.
  12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Throughout the entire duration of the study. Approximately 1 day per subject, due to early study Termination.

The study was discontinued by the sponsor, due to the manufacturer of the MiBo ThermoFlo receiving a warning letter from the FDA regarding non-compliance to 21 CFR part 820. Subsequently, the primary analyses were not carried.