Trial Outcomes & Findings for MiBo ThermoFlo Lid Temperature Evaluation (NCT NCT03787212)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

12-minutes post treatment

Results posted on

2020-02-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Test/Control 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.	Control/Test 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 1 STARTED	2	2
Period 1 COMPLETED	0	0
Period 1 NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control 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.	Control/Test 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 1 Study Termination	2	2

Baseline Characteristics

MiBo ThermoFlo Lid Temperature Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=4 Participants All subjects enrolled into the study prior to early study termination.
Age, Continuous	29.25 Years STANDARD_DEVIATION 7.847 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Count of Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Count of Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-minutes post treatment

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

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.

Outcome measures

Outcome measures
Measure	Test n=3 eyes Subjects that recieved the Test treatment during any point in this study	Control n=2 eyes Subjects that recieved the Control treatment at any point during this study.
Posterior Eyelid Temperature (Palpebral Conjunctiva) Left Eye - Lower Lid	37.835 Celcius Standard Deviation 0.9829	—
Posterior Eyelid Temperature (Palpebral Conjunctiva) Left Eye - Upper Lid	36.545 Celcius Standard Deviation 0.1485	—
Posterior Eyelid Temperature (Palpebral Conjunctiva) Right Eye - Lower Lid	37.42 Celcius Standard Deviation 0	37.415 Celcius Standard Deviation 0.5162
Posterior Eyelid Temperature (Palpebral Conjunctiva) Right Eye - Upper Lid	35.77 Celcius Standard Deviation 0	37.19 Celcius Standard Deviation 0.1131

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chantal Coles-Brennan, OD - Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904 443 3449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60