Evaluation of the LipiFlow System With a New Activator

• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04500821
• Collaborator: (none)
• Enrollment: 44
• Locations: 3
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site: 14.7
• Patients Per Site Per Month: 15.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Device: Activator LFD-2100	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
• Actual Study Start Date: Oct 2, 2020
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Activator LFD-2100 LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD	Device: Activator LFD-2100; LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD

Outcome Measures

Primary Outcome Measures

1. Successful Completion of LipiFlow Treatment With Activator LFD-2100 [1 day after completion of LipiFlow treatment]

   Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Empire Eye and Laser Center	Bakersfield	California	United States	93309
2	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
3	Texas Eye Research Center	Hurst	Texas	United States	76054

Sponsors and Collaborators

• Johnson & Johnson Surgical Vision, Inc.

Investigators

• Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical vision

Study Documents (Full-Text)

• Study Protocol - Aug 31, 2020
• Statistical Analysis Plan - Sep 17, 2020

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Surgical Vision, Inc.
• ClinicalTrials.gov Identifier: NCT04500821
• Other Study ID Numbers: DRYE-105-ACTS
• First Posted: Aug 5, 2020
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

Participant Flow

Pre-assignment Detail	A total of 88 eyes of 44 subjects with meibomian gland dysfunction were enrolled.

Arm/Group Title	Activator LFD-2100
Arm/Group Description	Lipiflow treatment with Activator LFD-2100
Period Title: Overall Study
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Activator LFD-2100
Arm/Group Description	Lipiflow treatment with Activator LFD-2100
Overall Participants	44
Age, Customized (Number) [Number]
< 30 years	0 0%
30-39 years	0 0%
40-49 years	1 2.3%
50-59 years	6 13.6%
60-69 years	19 43.2%
>= 70 years	18 40.9%
Sex: Female, Male (Count of Participants)
Female	31 70.5%
Male	13 29.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 6.8%
Not Hispanic or Latino	41 93.2%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Number) [Number]
Asian	2 4.5%
Black	0 0%
Native Hawaiian/Pacific Islander	0 0%
Caucasian	42 95.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated eyes

Arm/Group Title	Activator LFD-2100
Arm/Group Description	LipiFlow treatment with Activator LFD-2100
Measure Participants	44
Measure Eyes	88
Number (95% Confidence Interval) [Percent of eyes]	100

Adverse Events

Time Frame	During the course of the study until completion, 1 up to 2 days.
Adverse Event Reporting Description	Analysis population include all eyes (88 eyes) of 44 participants treated with Lipiflow with Activator LFD-2100. All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for each eye separately.
Arm/Group Title	Right Eye (OD)		Left Eye (OS)
Arm/Group Description	LipiFlow treatment with Activator LFD-2100		LipiFlow treatment with Activator LFD-2100
All Cause Mortality
	Right Eye (OD)		Left Eye (OS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	Right Eye (OD)		Left Eye (OS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Right Eye (OD)		Left Eye (OS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.