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MiBo ThermoFlo Lid Temperature Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787212
Recruitment Status : Terminated (Study terminated due to safety assessment of the study product)
First Posted : December 26, 2018
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Dry Eye Device: MiBo ThermoFlo Device: Bruder Mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MiBo ThermoFlo Lid Temperature Evaluation
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019

Arm Intervention/treatment
Experimental: MiBo ThermoFlo / Bruder mask
Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
Device: MiBo ThermoFlo
Test Device

Device: Bruder Mask
Control Device

Experimental: Bruder Mask / MiBo ThermoFlo
Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
Device: MiBo ThermoFlo
Test Device

Device: Bruder Mask
Control Device




Primary Outcome Measures :
  1. Posterior Eyelid Temperature (Palpebral Conjunctiva) [ Time Frame: 12-minutes post treatment ]
    Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of >40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787212


Locations
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United States, Texas
University of Houston, College of Optometry
Houston, Texas, United States, 77204
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03787212    
Other Study ID Numbers: CR-6281
First Posted: December 26, 2018    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes