Evaluation of the LipiFlow System With a New Activator
Primary Purpose
Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activator LFD-2100
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
To be able to participate in this study, subjects must:
- Be at least 22 years old.
- Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
- Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
- Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
- Ability to understand and respond in English.
Exclusion Criteria:
Subject will not be able to be in the study, if the subject:
- Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
- Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
- Is pregnant, or is breast feeding.
- Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Sites / Locations
- Empire Eye and Laser Center
- Wolstan & Goldberg Eye Associates
- Texas Eye Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activator LFD-2100
Arm Description
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
Outcomes
Primary Outcome Measures
Successful Completion of LipiFlow Treatment With Activator LFD-2100
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Secondary Outcome Measures
Full Information
NCT ID
NCT04500821
First Posted
July 22, 2020
Last Updated
January 13, 2022
Sponsor
Johnson & Johnson Surgical Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04500821
Brief Title
Evaluation of the LipiFlow System With a New Activator
Official Title
Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activator LFD-2100
Arm Type
Experimental
Arm Description
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
Intervention Type
Device
Intervention Name(s)
Activator LFD-2100
Intervention Description
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
Primary Outcome Measure Information:
Title
Successful Completion of LipiFlow Treatment With Activator LFD-2100
Description
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Time Frame
1 day after completion of LipiFlow treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be able to participate in this study, subjects must:
Be at least 22 years old.
Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
Ability to understand and respond in English.
Exclusion Criteria:
Subject will not be able to be in the study, if the subject:
Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
Is pregnant, or is breast feeding.
Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical vision
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye and Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Texas Eye Research Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu
Learn more about this trial
Evaluation of the LipiFlow System With a New Activator
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