MiBo ThermoFlo Lid Temperature Evaluation

Johnson & Johnson (J&J)

Status

Terminated

Conditions

Dry Eye

Treatments

Device: MiBo ThermoFlo

Device: Bruder Mask

Study type

Interventional

Funder types

Industry

Identifiers

NCT03787212

CR-6281

Details and patient eligibility

About

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

Enrollment

4 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).