MiBo ThermoFlo Lid Temperature Evaluation

NCT03787212 | Terminated Results FDA Device

• 1 other identifier: CR-6281
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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.

  12-minutes post treatment

Study Arms (2)

MiBo ThermoFlo / Bruder mask

EXPERIMENTAL

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; Device: Bruder Mask

Bruder Mask / MiBo ThermoFlo

EXPERIMENTAL

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; Device: Bruder Mask

Interventions

MiBo ThermoFlo DEVICE

Test Device

Bruder Mask / MiBo ThermoFlo; MiBo ThermoFlo / Bruder mask

Bruder Mask DEVICE

Control Device

Bruder Mask / MiBo ThermoFlo; MiBo ThermoFlo / Bruder mask

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

University of Houston, College of Optometry

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and 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.

Results Point of Contact

• Title: Chantal Coles-Brennan, OD - Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

CColesb@its.jnj.com

904 443 3449

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 26, 2018
• Study Start: December 6, 2018
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (1)