Dry Eye
Conditions
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.
Interventions
DEVICEMiBo ThermoFlo
Test Device
DEVICEBruder Mask
Control Device
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into the study prior to early study termination. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Study Termination | 2 | 2 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 29.25 Years STANDARD_DEVIATION 7.847 |
| Race/Ethnicity, Customized Asian | 1 Count of Participants |
| Race/Ethnicity, Customized White | 3 Count of Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 12-minutes post treatment
Population: All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Left Eye - Lower Lid | 37.835 Celcius | Standard Deviation 0.9829 |
| Test | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Left Eye - Upper Lid | 36.545 Celcius | Standard Deviation 0.1485 |
| Test | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Right Eye - Lower Lid | 37.42 Celcius | Standard Deviation 0 |
| Test | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Right Eye - Upper Lid | 35.77 Celcius | Standard Deviation 0 |
| Control | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Right Eye - Lower Lid | 37.415 Celcius | Standard Deviation 0.5162 |
| Control | Posterior Eyelid Temperature (Palpebral Conjunctiva) | Right Eye - Upper Lid | 37.19 Celcius | Standard Deviation 0.1131 |