Status:
TERMINATED
MiBo ThermoFlo Lid Temperature Evaluation
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03787212
Start Date
December 6 2018
End Date
January 28 2019
Last Update
February 5 2020
Active Locations (1)
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1
University of Houston, College of Optometry
Houston, Texas, United States, 77204