MiBo ThermoFlo Lid Temperature Evaluation

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03787212
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: MiBo ThermoFlo; Device: Bruder Mask	N/A

Study Design

• Study Type: Interventional
• 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: Dec 6, 2018
• Actual Primary Completion Date: Jan 28, 2019
• Actual Study Completion Date: Jan 28, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Posterior Eyelid Temperature (Palpebral Conjunctiva) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston, College of Optometry	Houston	Texas	United States	77204

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 15, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03787212
• Other Study ID Numbers: CR-6281
• First Posted: Dec 26, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• 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
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Recruitment Details	A total of 4 subjects were enrolled into this study prior to its termination. This study was terminated early by the sponsor due to a warning letter from the FDA regarding non-compliance to 21 CFR part 820.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects randomized to this sequence received the MiBo ThermoFlo as Test in their left eye and then received the Bruder Moist Heat Single Eye Compress as Control in their right eye.	Subjects randomized to this sequence received the Bruder Moist Heat Single Eye Compress as Control in their left eye and then received the MiBo ThermoFlo as Test in their right eye
Period Title: Period 1
STARTED	2	2
COMPLETED	2	2
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	2	2
COMPLETED	0	0
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into the study prior to early study termination.
Overall Participants	4
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.25 (7.847)
Sex: Female, Male (Count of Participants)
Female	3 75%
Male	1 25%
Race/Ethnicity, Customized (Count of Participants) [Number]
White	3 75%
Asian	1 25%
Region of Enrollment (Count of Participants)
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.

Arm/Group Title	Test	Control
Arm/Group Description	Subjects that recieved the Test treatment during any point in this study	Subjects that recieved the Control treatment at any point during this study.
Measure Participants	3	2
Measure eyes	3	2
Left Eye - Lower Lid	37.835 (0.9829)
Left Eye - Upper Lid	36.545 (0.1485)
Right Eye - Lower Lid	37.42 (0)	37.415 (0.5162)
Right Eye - Upper Lid	35.77 (0)	37.19 (0.1131)

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 1 day per subject, due to early study Termination.
Arm/Group Title	Test		Control
Arm/Group Description	Subjects that recieved the Test treatment during any point in this study		Subjects that recieved the Control treatment at any point during the study.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

The study was discontinued by the sponsor, due to the manufacturer of the MiBo ThermoFlo receiving a warning letter from the FDA regarding non-compliance to 21 CFR part 820. Subsequently, the primary analyses were not carried.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.