MiBo ThermoFlo Lid Temperature Evaluation

NCT ID: NCT03787212

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2019-01-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MiBo ThermoFlo

Intervention Type: DEVICE

Test Device

Bruder Mask

Intervention Type: DEVICE

Control Device

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.

Group Type: EXPERIMENTAL

MiBo ThermoFlo

Intervention Type: DEVICE

Test Device

Bruder Mask

Intervention Type: DEVICE

Control Device

Interventions

MiBo ThermoFlo

Test Device

Intervention Type: DEVICE

Bruder Mask

Control Device

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Houston, College of Optometry

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6281

Identifier Type: -

Identifier Source: org_study_id