MiBo ThermoFlo Lid Temperature Evaluation



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 80
Updated:3/9/2019
Start Date:December 6, 2018
End Date:January 28, 2019

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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).
We found this trial at
1
site
4901 Calhoun Road
Houston, Texas 77204
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mi
from
Houston, TX
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