Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 25, 2018
Last Update Posted : March 7, 2019
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

Layout table for study information
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. Palpebral Conjunctival Temperature [ Time Frame: 12 minutes post MiBo ThermoFlo treatment ]
    The surface temperature of the inner eyelid will be collected using infrared imaging in degrees Fahrenheit.

  2. Palpebral Conjunctival Temperature [ Time Frame: 10 minutes post Bruder mask treatment ]
    The surface temperature of the inner eyelid will be collected using infrared imaging in degrees Fahrenheit.


Secondary Outcome Measures :
  1. Tear Film Lipid Layer Thickness (LLT) [ Time Frame: 12 minutes post MiBo ThermoFlo treatment ]
    The tear film LLT will be measured in nm using an interferometer.

  2. Tear Film Lipid Layer Thickness (LLT) [ Time Frame: 10 minutes post Bruder Mask treatment ]
    The tear film LLT will be measured in nm using an interferometer.

  3. Non-invasive tear break up time (NITBUT) [ Time Frame: 12 minutes post MiBo ThermFlo treatment ]
    Time measurement of tear break-up will be taken using keratography.

  4. Non-invasive tear break up time (NITBUT) [ Time Frame: 10 minutes post Bruder Mask treatment ]
    Time measurement of tear break-up will be taken using keratography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
United States, Texas
University of Houston, College of Optometry
Houston, Texas, United States, 77204
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03787212     History of Changes
Other Study ID Numbers: CR-6281
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes