MiBo ThermoFlo Lid Temperature Evaluation

Stopped early · Not applicable

Conditions studied: Dry Eye

In brief

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

Key facts

Study ID

NCT03787212

Run by

Johnson & Johnson Vision Care, Inc.

People needed

4

Starts

2018-12-06

Expected to finish

2019-01-28

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Potential subjects must satisfy all the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Between 18 and 80 (inclusive) years of age at the time of screening.
• Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

You may not qualify if…

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or breastfeeding.
• 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.
• 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).
• Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading scale.
• Any active Ocular Infection or Inflammation
• Any history of eyelid surgery or abnormality
• History of Metal Implants in the Eyelids
• Any known hypersensitivity or allergic reaction to ultrasound coupling gel.
• LASIK Surgery within 2 weeks of the Baseline Visit.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Where it is running

• University of Houston, College of Optometry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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