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MiBo ThermoFlo Lid Temperature Evaluation

Primary Purpose

Dry Eye

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MiBo ThermoFlo
Bruder Mask
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Houston, College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MiBo ThermoFlo / Bruder mask

Bruder Mask / MiBo ThermoFlo

Arm Description

Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.

Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.

Outcomes

Primary Outcome Measures

Posterior Eyelid Temperature (Palpebral Conjunctiva)
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.

Secondary Outcome Measures

Full Information

First Posted
December 24, 2018
Last Updated
January 17, 2020
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03787212
Brief Title
MiBo ThermoFlo Lid Temperature Evaluation
Official Title
MiBo ThermoFlo Lid Temperature Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to safety assessment of the study product
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiBo ThermoFlo / Bruder mask
Arm Type
Experimental
Arm Description
Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
Arm Title
Bruder Mask / MiBo ThermoFlo
Arm Type
Experimental
Arm Description
Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.
Intervention Type
Device
Intervention Name(s)
MiBo ThermoFlo
Intervention Description
Test Device
Intervention Type
Device
Intervention Name(s)
Bruder Mask
Intervention Description
Control Device
Primary Outcome Measure Information:
Title
Posterior Eyelid Temperature (Palpebral Conjunctiva)
Description
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.
Time Frame
12-minutes post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
Facility Information:
Facility Name
University of Houston, College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

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MiBo ThermoFlo Lid Temperature Evaluation

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