Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
Phase: NA
Conditions: Meibomian Gland Dysfunction
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
EVALUATION OF THE LIPIFLOW SYSTEM WITH 
A NEW ACTIVATOR (MODEL LFD-2100) 
 
 
NCT Number: NCT04500821 
Document date: 31 Aug 2020 
 
 
 
 
 
 

 
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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision Inc. 
Evaluation of the LipiFlow System with a New Activator (Model LFD-2100) 
 
PROTOCOL NUMBER:  DRYE-105-ACTS 
 
SPONSOR: Johnson & Johnson Surgical Vision Inc. 
1700 East Saint Andrew Place 
Santa Ana, California 92705 
(714) 247-8200 
 
Investigator Agreement: 
As an Investigator, I agree to: 
 
Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155 and all 
other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA; and all other applicable laws 
and regulations. 
 
Supervise all testing of the device where human subjects are involved. 
 
Ensure that the requirements for obtaining informed consent are met. 
 
Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
 
Maintain all information supplied by Johnson & Johnson Surgical Vision in 
confidence and, when this information is submitted to an independent IRB/IEC or 
any other group, it will be submitted with a designation that the material is 
confidential. 
 
I have read this Protocol in its entirety, and I agree to all aspects. 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
Subinvestigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
Subinvestigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
Subinvestigator Printed Name 
Signature 
Date 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................... II 
PROTOCOL CHANGE HISTORY ................................................................................ V 
1. 
SYNOPSIS........................................................................................................ 1 
2. 
BACKGROUND/INTRODUCTION ..................................................................... 4 
3. 
CLINICAL HYPOTHESIS................................................................................... 5 
4. 
STUDY DESIGN ............................................................................................... 5 
5. 
ACRONYMS ..................................................................................................... 5 
6. 
STUDY OBJECTIVES AND ENDPOINTS .......................................................... 5 
7. 
STUDY PRODUCTS ......................................................................................... 5 
8. 
STUDY POPULATION ...................................................................................... 6 
9. 
INVESTIGATOR SELECTION ........................................................................... 7 
9.1 INVESTIGATOR QUALIFICATIONS ...........................................................................7 
9.2 INVESTIGATOR OBLIGATIONS................................................................................7 
9.3 INVESTIGATOR APPROVAL....................................................................................8 
10. 
EXPERIMENTAL PLAN..................................................................................... 9 
10.1 OVERVIEW..........................................................................................................9 
10.2 VISIT SCHEDULE ...............................................................................................10 
10.3 
PROCEDURES ...............................................................................................11 
Informed Consent................................................................................................11 
Screening & Enrollment .......................................................................................12 
LipiFlow Treatment..............................................................................................14 
Questionnaire .....................................................................................................15 
10.4 
ACTIVATOR SUPPLY.......................................................................................16 
10.5 
EXIT OF SUBJECTS ........................................................................................16 
10.6 
UNSCHEDULED VISITS ...................................................................................16 
10.7 
PROTOCOL DEVIATIONS .................................................................................16 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS....................................... 17 
11.1 
DEFINITIONS .................................................................................................17 
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION.....................................18 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS.........................18 
11.4 
CAUSAL RELATIONSHIP ..................................................................................19 
11.5 
ADVERSE EVENT FOLLOW-UP .........................................................................20 
12.0 
PROTOCOL CHANGES/AMENDMENTS ........................................................ 20 

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13. 
ETHICS REVIEW AND SUBJECT WELFARE.................................................. 21 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) ..............................................................21 
13.2 
INFORMED CONSENT .....................................................................................21 
14. 
DOCUMENTATION ......................................................................................... 22 
14.1 
SOURCE DOCUMENTS....................................................................................22 
14.2 
SUBJECT CONFIDENTIALITY ............................................................................22 
14.3 
CASE REPORT FORM COMPLETION .................................................................22 
14.4 
STUDY SUMMARY ..........................................................................................23 
15. 
MONITORING ................................................................................................. 23 
15.1 
DATA MONITORING ........................................................................................23 
15.2 
ADMINISTRATIVE MONITORING ........................................................................23 
15.3 
SAFETY MONITORING ....................................................................................24 
16.0 
PUBLICATIONS .............................................................................................. 24 
17.0 
RISK ANALYSIS ............................................................................................. 25 
18.0 
RECORDS RETENTION ................................................................................. 26 
19.0 
TERMINATION OF THE INVESTIGATION ...................................................... 26 
20.0 
STATISTICAL METHODS ............................................................................... 27 
20.1 ANALYSIS POPULATION......................................................................................27 
20.2 STUDY ENDPOINTS............................................................................................27 
20.3 SAMPLE SIZE CALCULATIONS .............................................................................28 
APPENDIX A. QUESTIONNAIRE - LIPIFLOW TREATMENT WITH ACTIVATOR LFD-
2100 ............................................................................................................... 28 
APPENDIX B  EQUIPMENT LIST ............................................................................... 34 
APPENDIX C  SUMMARY OF PROCEDRUES REQUIRED AT EACH VISIT............... 35 
APPENDIX D  SLIT-LAMP EVALUATION ................................................................... 36 
APPENDIX E   INSTRUCTIONS FOR MEIBOMIAN GLAND ASSESSSMENT  ............ 38 
APPENDIX F   INSTRUCTIONS FOR OCULAR SURFACE STAINING ....................... 42 
Corneal Staining .................................................................................................42 
Conjunctival Staining ...........................................................................................43 
APPENDIX G. ADVERSE EVENT AND COMPLAINT REPORTING INSTRUCTIONS . 44 
 
 
 
 
 
 
 

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PERSONNEL AND FACILITIES  
 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. (“JJSV”) 
 
1700 East Saint Andrew Place 
 
Santa Ana, CA 92705 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor: 
 
 
 
 
 
Medical Safety Officer:               
 
 
 
 
 
Sr. Manager, Clinical Operations:
 
 
 
 
 
 
Study Manager: 
 
 
 
 
 
 
 
Clinical Research Scientist: 
 
 
 
 
 
 
 
 
 
 
 
 
Biostatisticians: 
 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
  
 
 

 
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PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original. 
N/A. 
2.0 
1, 4, 10 
1, 2, 5, 
and 9 
Update the sample size. 
To allow more patients to be treated with 
Activator LFD-2100 in the study. 
10.3 
14-15 
Update the LipiFlow treatment procedures. 
To align with the latest LipiFlow Thermal 
Pulsation System Instructions for Use. 
11 
17 
Add the list of “Study-Specific Anticipated Adverse Events”. 
To clarify the study-specific anticipated AEs. 
Appendix A 
25-30 
Update the investigator questionnaire. 
To collect more feedback from investigators. 
Appendix G 
44 
Add “Adverse Event and Complaint Reporting Instructions” as 
Appendix G. 
To provide instructions on Adverse Event and 
Complaint reporting. 
Personnel and 
Facilities, and 
Appendix G 
iv, 44 
Update information of the study manager. 
To list the new study manager and his contact 
information. 
3.0 
1, 20.3 
4, 28 
Update the sample size calculation, meanwhile the overall 
sample size is not changed and will not impact the date 
collection. 
To update sample size calculation 

 
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1. 
SYNOPSIS 
PROTOCOL: 
Evaluation of the LipiFlow System with a New Activator 
(Model LFD-2100) 
Protocol Number:  DRYE-105-ACTS 
STUDY TREATMENTS: 
Investigational Product: The new Activator (Model LFD-
2100). 
STUDY OBJECTIVE: 
The purpose of this study is to confirm the clinical use of 
the LipiFlow system with Activator LFD-2100 to 
successfully complete LipiFlow treatment procedure in 
human subjects.  Additionally, the investigator rating of the 
ease of use of the LipiFlow system with Activator LFD-
2100 will be obtained.   
CLINICAL HYPOTHESIS: 
The Activator Model LFD-2100 will provide successful 
LipiFlow treatments in 95% or more cases. 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, open-label clinical study.  
Number of sites: 
Three (3) to 5 investigators in up to 4 sites in the USA. 
Duration: 
A pre-treatment visit and a treatment visit (may happen on 
the same day)  
Administration: 
Minimum 50 eyes and up to 100 eyes will be treated in this 
study.  The investigators or designees will perform LipiFlow 
treatment with the Activators LFD-2100 on both eyes.  The 
Investigator or designee will complete a questionnaire 
regarding the clinical use of Activator LFD-2100.  The 
treatment reports automatically generated by LipiFlow 
Console after completion of each treatment will be 
collected. 
Visit Schedule: 
Each subject will have 1-2 visits which include informed 
consent, screening for study participation, and receiving 
the LipiFlow treatment.  A questionnaire will be completed 
by the investigator or designee.  A typical pre-treatment 
visit will be approximately 30-60 minutes long, and a 
typical treatment visit will take another 30-60 minutes. 

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STUDY POPULATION CHARACTERISTICS: 
Condition: 
Adults with bilateral meibomian gland dysfunction (MGD) 
(refer to inclusion/exclusion criteria for requirements). 
Number of Subjects/Eyes: Minimum 50 eyes and up to 100 eyes to be treated.  
Each research subject must meet the following inclusion/exclusion criteria in order to 
participate in this study: 
Inclusion Criteria (all criteria apply to each study eye): 
 
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 (see Appendix E). 
• 
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 (all criteria apply to each study eye): 
 
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 (refer to the LipiFlow 
Thermal Pulsation System Instructions for Use for details) 
• 
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. 

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STUDY ENDPOINTS: 
 
Primary Endpoint: 
 Successful completion of LipiFlow treatment with Activator LFD-2100 in 95% or 
more cases. 
Other Endpoints: 
 Questionnaire rating of each step in the LipiFlow treatment procedure with 
Activator LFD-2100. 
 Rate of adverse events and complications. 
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the enrollment visit according 
to the inclusion/exclusion criteria.   
The Informed Consent Document and Authorization for Use/Disclosure of Health 
Information form to comply with US Health Information Portability and Accountability Act 
(HIPAA) must be signed by any subjects who agree to participate in the study prior to 
undergoing any study-specific procedures.   
After determination that all inclusion/exclusion criteria have been met, enrolled 
subjects will receive the LipiFlow system treatment on both eyes.  The investigator or 
designee will complete a questionnaire regarding the clinical use of Activators LFD-2100 
for each subject (see Appendix A).  
VISIT PROCEDURES: 
1) Informed consent.  
2) Screening and enrollment. 
3) Perform a pre-treatment slit lamp evaluation, non-dilated fundus exam, ocular 
surface staining for all the subjects, and optional meibomian gland assessment at 
the investigator’s discretion.  
4) Complete a bilateral LipiFlow treatment with Activators LFD-2100 on both eyes of 
a subject, and collect the treatment reports automatically generated by LipiFlow 
console after completion of each treatment 
5) Perform a post-treatment slit lamp evaluation and ocular surface staining.  
6) Questionnaire: The Investigator or designee will complete a questionnaire 
regarding the clinical use of Activator LFD-2100 (see Appendix A). 

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DATA ANALYSIS: 
The investigator or designee will complete a questionnaire on each step of the LipiFlow 
procedure with Activators LFD-2100 (see Appendix A) for each subject.  The treatment 
reports automatically generated by LipiFlow console after the completion of each 
treatment will be analyzed and used to evaluate successful completion of the procedure.   
SAMPLE SIZE CALCULATION: 
The confidence interval approach is used to estimate precision around the true 
proportion of successful completion of LipiFlow treatment with Activator LFD-2100.  
Assuming the proportion of successful completion of LipiFlow treatment is 95%, with n= 
50 eyes, a two-sided 95% confidence interval will be (89%, 100%), i.e., a precision of 
6.0%. 
2. 
BACKGROUND/INTRODUCTION 
As defined by the Tear Film and Ocular Surface Society (TFOS) International Workshop 
on meibomian gland dysfunction (MGD) involving more than 50 clinical and research 
experts, “Meibomian gland dysfunction is a chronic, diffuse abnormality of the 
meibomian glands, commonly characterized by terminal duct obstruction and/or 
qualitative/quantitative changes in the glandular secretion.  It may result in alteration of 
the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular 
surface disease.” 1 
The LipiFlow® Thermal Pulsation System is designed to apply localized heat and 
pressure therapy to the eyelids, in subjects with chronic cystic conditions of the eyelids, 
including MGD.  The LipiFlow provides controlled, localized heat and pressure 
application to the eyelids as a prescription device used in a 12-minute in-office 
procedure by a licensed physician or technician (by the order of a licensed physician).  
The LipiFlow uses an efficient method of melting the meibomian gland obstructions by 
applying heat to the inner eyelid surface, in closest proximity to the meibomian glands.  
Additionally, the LipiFlow improves upon the physician practice of manual eyelid 
expression by expressing the glands at a level of force far below that required to 
manually express the glands without heat.  The use of LipiFlow has been reported in 
several publications and presentations to date.  Prior clinical studies demonstrate safety, 
effectiveness and clinical utility of the LipiFlow system with Activator LFD-2000. 
 
1 Nichols KK, Foulks GN, Bron AJ, et al.  The international workshop on meibomian gland dysfunction: 
Executive summary. Invest Ophthalmol Vis Sci 2011;52(4):1922-29. 

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JJSV has developed a new model of Activator (Model LFD-2100). The purpose of this 
study is to evaluate the clinical use of the LipiFlow System with the Activator LFD-2100 
to complete a LipiFlow treatment procedure in human subjects. 
3. 
CLINICAL HYPOTHESIS 
The Activator Model LFD-2100 will provide successful LipiFlow treatments in 95% or 
more cases. 
4. 
STUDY DESIGN 
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. 
5. 
ACRONYMS 
• 
FDA: Food and Drug Administration 
• 
IEC: Independent Ethics Committee 
• 
IRB: Institutional Review Board 
• 
MGD: Meibomian Gland Dysfunction 
• 
MGE: Meibomian Gland Evaluator 
• 
JJSV: Johnson & Johnson Surgical Vision  
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this study is to confirm the clinical use of the LipiFlow system with 
Activator LFD-2100 to successfully complete a LipiFlow treatment procedure in human 
subjects.  Additionally, the investigator rating of the ease of use of the LipiFlow system 
with Activator LFD-2100 will be obtained.  
7. 
STUDY PRODUCTS 
The LipiFlow® Thermal Pulsation System is a prescription device with an indication for 
use for the application of localized heat and pressure therapy in adult patients with 
chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also 
known as evaporative dry eye or lipid deficiency dry eye.  The LipiFlow is used by a 

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physician or technician in an in-office procedure to provide controlled heat to the inner 
eyelid surface and intermittent pressure to the outer eyelid to facilitate release of lipid 
from the cystic glands.   
The LipiFlow has been most-recently cleared under pre-market notification (K192623)  to 
market the device in the U.S (Class II device).  The LipiFlow with the existing Activator 
Model LFD-2000 is in commercial distribution based upon a determination by the FDA 
that the device is substantially equivalent to a legally marketed device.  The new 
Activator Model LFD-2100 is a modification of LFD-2000.   The risk assessment 
supports that the use of the LipiFlow with LFD-2100 in this study is non-significant risk 
because the system is designed to control the application of heat and pressure within a 
safe range and time.  The use of the newly designed LFD-2100 does not change the 
overall residual risk of the device or introduce new risks to the patient and/or user as 
compared to the Activator Model LFD-2000. No new potential hazards and harms to the 
patient or user were identified for the device modifications relative to the existing risk 
assessment for the Activator Model LFD-2000. The risk assessment was conducted to 
confirm that the change from LFD-2000 to LFD-2100 does not trigger any new risks, as 
the design specifications of the activator between the iterations remained unchanged, 
and that the main clinical efficacy intended use of regulated heat and pressure delivery 
to the eyelid remained unchanged. 
8. 
STUDY POPULATION 
Each research subject must meet the following inclusion/exclusion criteria in order to 
participate in this study: 
Inclusion Criteria (all criteria apply to each study eye): 
 
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 (see Appendix E). 
• 
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 (all criteria apply to each study eye): 
 
Subject will not be able to be in the study, if the subject: 

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• 
Has a history of certain medical conditions that have been identified as 
contraindications and precautions of the LipiFlow System (refer to the LipiFlow 
Thermal Pulsation System Instructions for Use for details). 
• 
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. 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select the existing LipiFlow users who are licensed to practice medicine and 
are experienced in performing the LipiFlow treatment at the investigative site. 
Investigators will be selected from either ophthalmologists, optometrists, or technicians 
who are experienced in LipiFlow treatment with Activator LFD-2000. Licensed 
ophthalmologists, optometrists and/or study coordinators with Good Clinical Practice 
(GCP) training, and experienced in conducting clinical trials in the fields of optometry 
and ophthalmology will consent subjects and perform screening as well as pre-, and 
post-treatment testing. 
The sites where this trial will be conducted are required to have adequate staff support, 
as well as the necessary instrumentation to conduct study testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol.  Investigator 
will only make changes to a protocol after notifying and obtaining approval from the 
IRB except when necessary to protect the safety, rights or welfare of subjects. 
• 
Personally conduct and supervise the study. 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties. 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care, with particular focus on assuring subjects are not improperly 
influenced or coerced toward participation. 
• 
Be responsible for the control and documentation of the devices under investigation. 

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• 
Inform subjects that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB approval are met 
according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations. 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations. 
• 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining IRB approval. 
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812. 
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations. 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either JJSV, duly authorized regulatory agencies (e.g., FDA) and/or the 
IRB. 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB at 
regular intervals, but no less often than yearly as required by 21CFR812.150. 
• 
Report all changes in research activity and all unanticipated problems involving risks 
to subjects to the IRB. 
• 
Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJSV’s request, 
return to JJSV any remaining supply of the investigational device. 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of the investigation or for up to one year following completion of the study 
• 
Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB, the FDA 
and the regulatory agency of the country in which the study is being conducted. 
• 
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the investigational device, their 
study-related duties and functions and agree to fulfill their obligations in meeting the 
above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify JJSV of any change in the conduct of 
the study including changes in study personnel assigned to the study project, location of 
the investigational device(s), or maintenance of study records, etc. 
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 

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documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to JJSV.  Study sites will obtain IRB approvals and fulfill 
any other site-specific and/or region-specific regulatory requirements.  The investigator 
is required to report to JJSV within five working days any withdrawal of approval by the 
reviewing IRB for his/her participation in the investigation.  
Prior to the start of subject enrollment, the following documents must be approved: 
• 
Confidentiality Agreement 
• 
Clinical Trial Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10. 
EXPERIMENTAL PLAN 
10.1 OVERVIEW 
The study will be conducted in accordance with the principles of the Declaration of 
Helsinki and in accordance with U.S. Code of Federal Regulations, ISO 14155 and all 
other applicable laws and regulations. The study will not begin until IRB approvals have 
been obtained.  
Study activities may be delegated to qualified study staff, but the Principle Investigator is 
responsible for all study activities.  Delegation must be documented before study 
activities commence.  Individuals involved in the conduct of this study will have 
documented training applicable to their respective roles. 
All tests in this protocol are to be performed by the investigators or designees who are 
representative of the end-user community for the LipiFlow system (e.g., 
ophthalmologists, optometrists and technicians).  All tests will be performed in a clinic, 
an office or laboratory setting and may be observed by JJSV personnel.  Three to five 
investigators or designees will perform the LipiFlow treatments per this protocol on 
approximately 25 – 50 subjects per investigator or designee, resulting in treatments in 
minimum 50 eyes and up to 100 eyes in total.  
Informed consent will be obtained for each subject prior to any study-specific activities.  
The subjects may refuse participation or exit the study at any time.  If new information 

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becomes available that may impact a subject’s willingness or ability to continue 
participation in the study, the informed consent form will be revised, and each subject 
will be re-consented. 
After screening and enrolment, if a subject meets all inclusion / exclusion criteria, the 
investigator or designee will perform a complete LipiFlow treatment with Activator LFD-
2100 on both eyes of a subject.   
The investigator or designee will complete a questionnaire regarding the clinical use of 
the Activator LFD-2100 (see Appendix A).  The treatment reports automatically 
generated by LipiFlow Console after completion of each treatment will be printed out and  
collected.  The reports will present confirmation of treatment completion together with 
treatment information such as the changes in pressure and temperature during the 
treatment. 
Typical duration of study exams and treatment will last approximately 1-2 hours.  All data 
will be de-identified or encoded to protect the privacy of the subject and confidentiality of 
the data.  Although the study is not masked, to maintain consistency, it is recommended 
that a single individual (study technician or coordinator designated by the investigator) 
conduct all study-related eye testing, although a back-up person should also be 
designated and trained.  
The investigators will be provided with the LipiFlow Consoles (if needed), LipiFlow 
Activator LFD-2100, Semi-permanent Cable, Lid Stabilizer Tape, and the LipiFlow, 
Activator, and Cable Instructions for Use (IFU), including the Quick Start Guide.  Prior to 
human use, Activator LFD-2100 will be described in sufficient details in a Clinical 
Investigator Brochure to adequately describe the theory of operation and compliance to 
applicable standards in humans. 
10.2 VISIT SCHEDULE 
Each subject will have a 1-2 study visits which include informed consent, screening for 
study participation and performing the LipiFlow treatment with Activator LFD-2100 (see 
Appendix C).  Unscheduled visits may be conducted as necessary at the discretion of 
the investigator for clinically-indicated follow-up. 
Inclusion and exclusion qualifications will be assessed prior to study treatment.  The 
Informed Consent Document must be signed by any subjects who agree to participate in 
the study prior to undergoing any study-specific procedures.   
Study parameters and methods are listed as below:  
1) Informed consent 

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2) Screening and Enrollment: including but not limited to reviewing medical and 
ocular history, discussing study eligibility etc.  
3) Perform a pre-treatment slit lamp evaluation, non-dilated fundus exam, ocular 
surface staining for all the subjects, and optional meibomian gland assessment at 
the investigator’s discretion.  
4) Complete a bilateral LipiFlow treatment with Activator LFD-2100 on both eyes of 
a subject, and collect the treatment reports automatically generated by the 
LipiFlow console after completion of each treatment. 
5) Perform a post-treatment slit lamp evaluation and ocular surface staining.  
6) Questionnaire: The Investigator or designee will complete a questionnaire 
regarding the clinical use of the Activator LFD-2100 (Appendix A). 
10.3 
PROCEDURES 
The procedures in the Pre-treatment visit include Informed Consent, Screening & 
Enrollment, and Pre-treatment slit lamp evaluation, non-dilated fundus exam, ocular 
surface staining, and optional meibomian gland assessment (at the investigator’s 
discretion).  The procedures in the Treatment Visit include LipiFlow Treatment, post-
treatment slit lamp evaluation, ocular surface staining, and completion of the 
Questionnaire.  These procedures must be done in the order shown as below. 
Informed Consent 
The Investigator or designee identifies potential study participants by reviewing medical 
records of subjects.  Potential study participants are scheduled for the study visit. 
At the visit, the Investigator or designee conducts the informed consent discussion and 
explains the study purpose, procedures, benefits, risks, discomforts, precautions and 
subject responsibilities to the potential study participant.  The Investigator may provide 
written delegation of authority to a trained and qualified study staff member (e.g., study 
coordinator, technician) to conduct the consent discussion; however, the Investigator 
should be available to answer the potential participant’s questions, as needed. 
Once the Investigator or designee has answered all the potential participant’s questions 
to his/her satisfaction and the potential study participant has voluntarily agreed to 
participate in the study, written informed consent is obtained using the IRB/IEC-
approved informed consent document.  The subject and the person conducting the 
consent discussion (Investigator or designee) print their names, sign and date the 
consent.  If the subject is unable to read, the consent document can be read to the 
subject in front of an impartial witness, who also prints his/her name, signs and dates the 
consent. 

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All subjects enrolled in the study must sign the current IRB/IEC-approved informed 
consent document.  The informed consent must be signed before any study-specific 
examinations are performed, and this must be documented in the source documents.  
An authorization for use/disclosure of health information form (HIPAA authorization) or 
similar medical measurement privacy law documentation must also be signed.   
The Investigator maintains the signed informed consent document and the signed 
authorization form as a permanent part of the subject’s medical records and provides a 
signed copy of the consent to the subject.  The Investigator or designee documents in 
the medical records that informed consent was obtained prior to any study-specific 
procedures and a copy of the signed consent was given to the subject. 
As the Informed Consent Form is signed prior to any study-specific procedures, some 
subjects may not qualify after study-specific testing is performed.  Subjects will be 
considered screen-failures if they do not qualify or if they qualify but decide not to 
proceed with study treatment.  These subjects will be exited from the study.   
Screening & Enrollment 
Following the informed consent process, the Investigator or designee will perform the 
screening exam procedures and evaluate the subject conditions that affect study 
eligibility, as listed in Sections 8.  The screening exam may be ended prior to 
completion if the Investigator or designee determines that the subject does not meet one 
or more of the eligibility criteria.  The subject must meet all the study inclusion / 
exclusion criteria based on testing and medical history discussion conducted at the visit. 
The screening exam to be performed for each eye includes: 
MEDICAL AND OCULAR HISTORY 
To determine the presence of any systemic or ophthalmic factors that may affect the 
subject’s eligibility based on the study inclusion and exclusion criteria in Sections 8, the 
Investigator or designee obtain the subject’s medical and ophthalmic history at the visit, 
including assessment of:   
1) demographic information (age, gender, race/ethnicity);  
2) ophthalmic conditions and medications;  
3) history of ocular surgery, ocular injury, ocular infection, ocular inflammation, 
ocular allergy, eyelid abnormality, or ocular surface abnormality; 
4) pregnant and breastfeeding conditions, if applicable;  
5) recent participation in another ophthalmic clinical trial; 
6) employment or relationship with any employee at the clinical study site. 
BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at the study visit to determine if the 
subject meets inclusion/exclusion criteria (see Appendix D).  The Investigator or 
designee evaluates the eyelids, palpebral and bulbar conjunctiva, cornea, anterior 

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chamber, iris and lens using a slit lamp biomicroscope.  The Investigator or designee 
everts the upper eyelid to evaluate the upper palpebral conjunctiva. The Investigator or 
designee assesses the findings for the presence of any medical findings. 
NON-DILATED FUNDUS EXAM    
A non-dilated fundus exam shall be performed at the study visit to determine the status 
of the ocular media, retina and lens and to determine if the subject meets 
inclusion/exclusion criteria. 
Potential participants who are approached with the informed consent document will be 
documented on the Subject Accountability Log.  A subject who does not meet the 
eligibility criteria or who chooses to discontinue study participation at any time is 
documented on the Subject Accountability Log as a Screen Failure or Exited Subject 
along with the reason. All subjects who sign the informed consent document are 
assigned a subject identifier. 
MEIBOMIAN GLAND ASSESSMENT (OPTIONAL) 
The MGD diagnosis can be based on prior medical records, investigator opinion, or in 
conjunction with an assessment of meibomian glands of the lower eyelid (see Appendix 
E).  The need for the meibomian gland assessment is at the investigator’s discretion. 
If the Investigator or designee decides to conduct the meibomian gland assessment to 
evaluate the function of the meibomian glands, the Investigator or designee can assess 
the color and consistency of the secretion characteristics from the gland orifices along 
the lower eyelid in each eye.  The Investigator or designee evaluates the glands using a 
slit-lamp biomicroscope and a handheld instrument, Meibomian Gland Evaluator (MGE) 
(as shown in Appendix E), to apply gentle pressure along the eyelid margin, which 
simulates a forceful blink in yielding secretions from the glands. This instrument provides 
a standardized method to apply the same amount of pressure at each visit and for each 
subject to ensure measurement consistency.  This Class I, 510(k)-exempt device is 
commercially available, and is being used in this study in accordance with the indications 
in the commercial product labeling. 
There are approximately 20 to 30 meibomian glands along the lower eyelid.  The 
Investigator or designee assesses and grades glands located temporally, centrally and 
nasally.  The central region of the Meibomian Gland Evaluator should be carefully placed 
in the temporal, central and nasal regions as described in Appendix E to avoid overlap 
in the gland assessment. 
OCULAR SURFACE STAINING 
Ocular surface staining of the cornea and conjunctiva shall be evaluated.  The 
Investigator or designee assesses the corneal staining after instillation of fluorescein dye 

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in the eye, and assesses the conjunctival staining after instillation of lissamine green dye 
in the eye, as defined in Appendix F. 
LipiFlow Treatment 
If a subject meets all inclusion / exclusion criteria, the investigator or designee will 
perform a complete LipiFlow treatment with the Activator LFD-2100 on both eyes of a 
subject. 
If the Treatment Visit doesn’t happen on the same day of the Pre-reatment Visit, a 
biomicroscopic slit-lamp exam must be performed before LipiFlow treatment performed 
at the Treatment visit to assess the findings for the presence of any medical findings. 
The Investigator or designee cleans the lid margin and then performs treatment with the 
LipiFlow system per the LipiFlow Thermal Pulsation System Instructions for Use.  The 
Investigator or designee documents any problems with the LipiFlow system during 
treatment.  The Sponsor will investigate any reported problem with the LipiFlow system. 
TREATMENT PROCEDURES 
1. Inspect expiration date on Activator LFD-2100 packaging and place Activators 
LFD-2100 in subject’s eyes. 
Inspect the expiration date on the Activator LFD-2100 packaging before using 
the Activator. Verify the date has not expired.  
1.1. Cable setup  
Prior to using Activator II (LFD-2000), the Cable (Model CBL-2000) must be 
attached to the Console and locked into place with the locking clip.  Plug the 
Cable connector into the Console and push the locking clip into the connector. 
1.2. Disinfect cable and connect Activator LFD-2100 
Disinfect the Cable plug to Activator LFD-2100 and tubing with isopropyl 
alcohol (70-90% concentration) prior to connection to the Activator LFD-2100. 
The investigator or designee will open the Activator LFD-2100 package 
consisting of the combined lid warmer and eye cup.  Before removing the 
Activator LFD-2100 from its package, connect the Cable to the Activator while 
inside the package to minimize user handling prior to insertion. Leave the 
Activator II inside the package until the Activator LFD-2100 self-test is 
completed. 
1.3. Run Activator LFD-2100 self-test:  

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Once the Activator LFD-2100 is connected, a message indicating that the 
system is running a Activator self-test is briefly displayed on the Console 
Treatment screen above the pressure sequence overview graph. 
1.4. Inspect and Placement of Activator LFD-2100:  
The investigator or designee will inspect the Activators LFD-2100 to ensure 
that there are no rough or sharp edges and then place the Activators LFD-2100 
in subject’s eyes. 
1.5. Stabilize the Activator LFD-2100:  
 Position the patient in a reclined or supine position for treatment. Place 2 
drops of commercially available anesthetic in the eye(s) to be treated. Once the 
Activator is placed correctly, secure the Activator with medical-grade adhesive 
tape (either the Lid Stabilizer or surgical tape). 
2. Run LipiFlow Treatment with Activator LFD-2100 
After securing the Activator LFD-2100, the investigator or designee will run and 
complete the LipiFlow treatment with the Activators and monitor the Activators 
position on the eyelids during treatment. 
3. Remove Activator LFD-2100 
3.1. Disconnect Activator LFD-2100 from subject’s eyes 
3.2. Disconnect Activator LFD-2100 from the Cables 
After completion of each treatment, the treatment reports automatically generated by 
LipiFlow Console will be printed out and collected. The reports will show completion of 
the treatment and additionally the changes of pressure and temperature during the 
treatment. 
Following the completion of LipiFlow treatment, the Investigator or designee will perform 
a slit-lamp evaluation (Appendix D) and ocular surface staining (Appendix F) in each 
eye to check for any adverse events.  
Questionnaire 
A questionnaire will be administered to the investigator or designee to collect information 
regarding the clinical use of Activator LFD-2100 (Appendix A). 

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10.4 
ACTIVATOR SUPPLY 
For all the study subjects, the Activators will be obtained from the site study consignment 
supplied by JJSV prior to the first study treatment.  One Activator will be used on each 
eye of a subject.  Unused back-up Activators are to be returned to the site consignment.  
At the completion of all study treatments, any remaining Activators will be shipped back 
to JJSV following the final accountability by a JJSV Study Monitor.  At all times, the 
storage, access and use of all the consignment Activators must be controlled.  
10.5 
EXIT OF SUBJECTS 
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.    
It is the responsibility of the investigator to provide complete follow-up data to JJSV for 
each subject, and every attempt should be made to gather that complete follow-up data 
for all subjects enrolled as missing data can have a negative effect on the study results.  
A subject will be considered a “screen failure” if he/she does not meet the 
inclusion/exclusion criteria or if consent is withdrawn prior to LipiFlow treatment.   
If a subject is exited early from the study, the investigator or designee will complete an 
Exit Case Report Form indicating the reason for study exit.  In the event of any serious 
adverse event, the subject may be exited from the study; however, efforts must be made 
by the investigator to follow the subject until resolution of the adverse event.   
Following study completion or early exit, all study subjects are to be instructed to 
undergo regular eye examinations at least yearly and also to return to their doctor if any 
eye complications are experienced in the interim. 
10.6 
UNSCHEDULED VISITS 
During the study period or immediately after (within 1-week), if a non-protocol-required 
visit is done for the purpose of medically-indicated follow-up for a study eye, data from 
this visit should be reported using the Unscheduled Visit CRF.  The need for 
unscheduled visits is at the investigator’s discretion.  Specific examinations to be 
performed at unscheduled visits are also at the discretion of the investigator (based on 
the reason for the unscheduled visit) and data are to be recorded in the appropriate 
section of the case report form. 
10.7 
PROTOCOL DEVIATIONS 
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 

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testing procedures, etc.).  All protocol deviations will be captured in the Electronic Data 
Capture (EDC) system.  Any deviation made to protect the life or physical wellbeing of a 
subject in an emergency as well as any use of the investigational device without 
obtaining informed consent must be reported to JJSV within 5 working days.  Protocol 
deviations will be monitored by JJSV, and if the non-compliance is persistent or 
egregious, JJSV may take action, including but not limited to termination of the 
investigator’s participation in the study.  The investigator is also responsible for informing 
the reviewing IRB of instances of protocol non-compliance in accordance with the IRB 
requirements. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS 
11.1 
DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• 
is sight- or life-threatening,  
• 
results in death,  
• 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in health is 
not considered a serious adverse event), 
• 
results in permanent impairment of a body structure or body function,  
• 
necessitates medical or surgical intervention to prevent permanent impairment to a 
body structure or function, or 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse even that is believed to be 
definitely, probably or possibly related to the study device.  A device-related event is also 
considered an adverse device effect (ADE; following ISO 14155) resulting from the use 
of the study device that may result from user error, insufficiencies or inadequacies in the 
instructions for use, deployment, implantation, installation, operation of any malfunction 
of the device.   

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Study-Specific Anticipated Adverse Events 
The study specific anticipated AEs are listed below and will be classified as AE or SAE 
dependent upon its occurrence and severity during the course of the study: 
• 
Eyelid/eye pain requiring discontinuation of the treatment procedure;  
• 
Eyelid irritation or inflammation (e.g. edema, bruising, blood blister, dermatitis, 
hordeolum or chalazion); 
• 
Ocular surface irritation or inflammation (e.g. corneal abrasion, conjunctival 
edema or conjunctival injection/hyperemia); and 
• 
Ocular symptoms (e.g. burning, stinging, tearing, itching, discharge, redness, 
foreign body sensation, visual disturbance, sensitivity to light). 
Study-Specific Serious Anticipated Adverse Events 
There is no anticipated study-specific serious adverse event for this study.  
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error and 
inadequacies in labeling.  Product complaints can pertain to any marketed JJSV device 
being used in the study.  The investigator is to assess whether the deficiency could have 
led to a serious adverse event without suitable action or intervention or under less 
fortunate circumstances. 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 
JJSV and recorded on the case report form corresponding to the visit during which 
awareness of the event occurred.  Adverse events are also to be reported to the 
reviewing IRB/IEC as per the IRB/IEC’s reporting requirements.  If required, adverse 

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events will be reported to the appropriate regulatory agencies according to all applicable 
laws and regulations.   
Reporting of adverse events shall follow the applicable Regulations.  General guidelines 
are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a 
timely manner.  Notification of non-serious and non-device related adverse events will 
occur by recording events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB/IEC per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse 
event without suitable action or intervention, or under less fortunate circumstances, must 
be reported to the sponsor immediately (no later than 24 hours after detection). Device 
deficiencies that could have led to a serious adverse event should also be reported to 
the investigator’s IRB/IEC per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device related events (ADEs) are to be documented using the Serious 
Adverse Event/Adverse Device Effect (SAE/ADE) CRF.  In the event of a serious 
adverse event (SAE), which may or may not be related to use of the study device, JJSV 
must be notified immediately (no later than 24 hours after detection).  Any SAE is to be 
reported by phone (and/or email) and by submitting the completed SAE/ADE CRF.  Any 
SAE or device-related AE should also be reported to the investigator’s IRB/IEC per their 
reporting requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJSV within 24 hours, and to 
the investigator’s IRB/IEC as soon as possible (and no later than 10 working days after 
learning of the event for sites in the USA as required by 21CFR812). 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine the 
causality of the event.  The following definitions are to be used as guidelines in 
determining the relationship between the event and the study device and/or use of the 
device.   

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Definitely related: 
If the event is associated with the device and/or the use of the 
device beyond a reasonable doubt, a causal relationship exists 
between the adverse event and the device and/or the use of the 
study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of the 
study device and/or the adverse event cannot be reasonably 
explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or the use of the device, but no other cause has been 
identified and the device and/or the use of the study device 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the device could 
exist, but the adverse event can be reasonably explained by 
another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
and/or the adverse event can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device and/or the use of the device, the event will be considered related to the study 
device and/or the use of the device.   
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  Obtain and maintain in the subject's files all 
pertinent medical data relating to the event including the subject’s medical records and 
medical reports and/or judgments from colleagues or outside specialists who assisted in 
the measurements of the subject. The investigator should keep JJSV closely informed 
as to the outcome of serious and/or device-related adverse events, thereby allowing 
JJSV to comply with the appropriate regulatory reporting requirements.  A SAE/ADE 
Follow-up CRF should be completed each time the subject returns to the investigator for 
follow-up of serious and/or device-related adverse event until resolution of the event.  
Any subject who is exited from the study due to a serious and/or device-related adverse 
event or prior to resolution of such an event will be followed until the outcome is 
determined. 
12.0 
PROTOCOL CHANGES/AMENDMENTS 
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from JJSV regarding the proposed changes prior to 

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implementation.  Any modifications (including additional data collection) require approval 
of the governing IRB prior to implementation.   
13. 
ETHICS REVIEW AND SUBJECT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
13.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent is to be signed and dated by the subject as well as by 
the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide JJSV written acknowledgement on the case report form that 
a signed agreement of informed consent has been obtained and is in the investigator’s 
possession for each subject.  As required by 21CFR812 Part G, the site shall document 
in the source documents that informed consent was obtained prior to participation in the 
study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form or 
equivalent documentation necessary to comply with applicable privacy laws pertaining to 
medical measurement in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 

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14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by JJSV: 
• 
Subject’s name and study identification number 
• 
Subject’s contact information 
• 
Study protocol number and the Sponsor name (JJSV) 
• 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• 
Dates of all subject visits throughout the duration of the study 
• 
Study measurements 
• 
Description of any adverse events and/or product complaints/device deficiencies and 
documentation of appropriate reporting 
• 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to the JJSV or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 
14.3 
CASE REPORT FORM COMPLETION 
This study will use the IBM Merge EDC system.  The investigator is responsible for 
ensuring that data are properly recorded on each subject’s case report form and related 
documents.  Prior to database lock, the investigator will verify completeness and 
accuracy of data submitted to JJSV.  

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14.4 
STUDY SUMMARY 
A final investigator’s summary will be provided to JJSV and the reviewing IRB within 3 
months after termination or the completion of the study or the investigator’s part of the 
investigation.  
15. 
MONITORING  
JJSV will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
15.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJSV will follow specific data monitoring 
procedures, routinely generate reports and periodically review safety and effectiveness 
data.  To avoid bias, any analyses generated prior to site closures will not be 
disseminated to any of the investigative sites.  
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, JJSV will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed on the case report forms at the investigative site and in the data management 
system at JJSV. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with 
centralized and on-site programs.  In addition, subjects will be encouraged at the time of 
informed consent to avoid missing study visits, as missing data may affect the study 
reliability and diminish the scientific value of their contribution to the study.  
15.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and forms 
can be traced and will allow monitoring of investigator progress and compliance.  
Accountability and traceability of study devices will be monitored, as needed for 
compliance with study requirements. 
Device Accountability 
Complete Activator accountability will be maintained at the investigative site by 
maintaining records of investigational product received from and returned to JJSV.  A 
site log will be used to track investigational equipment for date of receipt, use and 
disposition/return to JJSV.  This site log and any other investigational product 
information will be maintained in the study binder and monitored by JJSV personnel.  

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During periodic investigative site monitoring visits, JJSV personnel will review 
investigative product inventory records and logs to ensure Activator accountability 
compliance and complete investigational traceability.   
Site Monitoring Plan 
Prior to performing site initiation, the requirements of the study and reporting 
mechanisms will be explained to each investigator.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with JJSV or have undergone significant 
changes or have not been visited in the past year.  A study initiation visit may be 
conducted prior to the first treatment.  
Throughout the duration of the study, the compliance to this protocol will be monitored 
remotely or at each investigative site.  During interim site monitoring visits, JJSV will 
review informed consent documents and subject eligibility, and the data on study case 
report forms will be verified against subject charts and other source documents to 
ensure complete and accurate reporting.  The subject files will also be reviewed to 
assure that all adverse events and any issues encountered with JJSV products have 
been reported in a timely fashion.  
JJSV will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, 
for a list of items that are required for source documentation.   
Training on study-specific procedures may also be conducted during monitoring visits.  
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.   
15.3 
Safety Monitoring 
The medical monitor will review results throughout the clinical trial as necessary to 
ensure the continued safety of the device and to ensure that no subjects are exposed 
to unreasonable risk.  The medical monitor will be available to answer all questions 
from investigators.  The medical monitor will review and assess any reports of serious 
and/or device-related adverse events as well as device deficiencies that could have 
led to a serious adverse event and discuss these with the reporting investigator(s) as 
necessary.  The medical monitor, as well as any other qualified personnel designated 
by JJSV, shall also review any interim progress reports, as applicable. 
16.0 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication policies. 

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17.0 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS ASSOCIATED WITH USE OF LIPIFLOW 
The use of the LipiFlow System in this study is non-significant risk.  No device-related 
serious adverse events are anticipated with the use of the LipiFlow system. Transient, 
non-serious adverse events which may result from the use of the LipiFlow system 
include, but are not limited to, the onset or increase in the following ocular signs or 
symptoms that are either 1) clinically significant as determined by the Investigator, or 2) 
require medical treatment for resolution: 
• 
Eyelid/eye pain requiring discontinuation of the treatment procedure;  
• 
Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, 
hordeolum or chalazion); 
• 
Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema 
or conjunctival injection/hyperemia); and 
• 
Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign 
body sensation, visual disturbance, sensitivity to light). 
RISK MANAGEMENT 
Subjects will be closely monitored throughout the trial duration. The occurrence of 
adverse events and complaints will be assessed at each study visit and reported to JJSV 
according to Section 11.0, Adverse Events and Product Complaints.  Additionally, JJSV 
will monitor incoming data following the procedures outlined in Section 15.0, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and device-
deficiencies that could have led to serious adverse events (Section 15.3, Safety 
Monitoring).  
POTENTIAL BENEFITS 
There may not be any direct benefit for the subjects participating in the clinical study. 
The study will provide data to confirm the clinical use of the LipiFlow system with 
Activator LFD-2100 to successfully complete a LipiFlow treatment procedure in human 
subjects. 
CONCLUSION 
The hazards/risks associated with the LipiFlow system are acceptable.  The 
hazards/risks associated with the Activator Model LFD-2100 were mitigated to as low as 
possible, and residual risks were addressed via risk-benefits analysis.  The conclusion of 
the risk-benefits analysis was that the benefit gained from testing the Activator LFD-2100 
in the study outweighs the relatively low risk of harm after all mitigations are 
implemented when the devices are used as intended. 

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18.0 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of use of all study products, and original case report forms 
should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.  Note: This may be for a minimum of 15 years after 
completion of the study unless country-specific requirements are longer. JJSV requires 
notification if the investigator wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 
• 
All case report forms 
• 
All adverse event information (detailed adverse event forms, follow-up letters, etc.) 
• 
Investigational supply records/inventory 
• 
IRB approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries) 
• 
Subject medical chart/clinic notes (Not applicable for transfer of ownership to 
JJSV) 
19.0 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 

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If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA.  The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  
JJSV may also stop the study at any time for reasons it determines appropriate.  
However, no suspension of the study would be made to disadvantage the study 
subjects.  Following suspension of the study for any reason, all study subjects who have 
already received treatment would continue to be followed through completion of the 
study visit schedule.  
20.0 
STATISTICAL METHODS 
20.1 ANALYSIS POPULATION 
All treated subjects will be included in the analysis population.  All the questionnaire 
responses and the treatment reports generated by LipiFlow system after completion of 
treatment will be collected and analyzed to confirm successful completion of the 
procedure.  Questionnaire responses for each item and data from the treatment reports 
will be summarized for Activator LFD-2100.  No imputations for missing values will be 
used. 
20.2 STUDY ENDPOINTS 
Primary Endpoint: 
 Successful completion of LipiFlow treatment with Activator LFD-2100 in 95% or 
more cases. 
The treatment reports automatically generated by LipiFlow Console after 
completion of each treatment will show if the treatment completion is successful. 
The frequency and proportion of successful completion of treatment will be 
reported.  The expected proportion of successful completion of LipiFlow 
treatment question will be greater than or equal to 95%. 
Other Endpoints: 
 Questionnaire rating of each step in the LipiFlow treatment procedure with 
Activator LFD-2100. 
For questions with a ‘Yes’ or ‘No’ response, the frequency and proportion of each 
question with response ‘Yes’ will be reported.  For questions with five levels of 

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rating score responses, the frequency and proportion of each level of rating score 
responses will be tabulated.  The mean and median of rating score of each 
question will also be reported. 
 Rate of adverse events and complications. 
The type and rates of adverse events will be summarized.           
20.3 SAMPLE SIZE CALCULATIONS 
The confidence interval approach is used to estimate precision around the true 
proportion of successful completion of LipiFlow treatment with Activator LFD-2100.  
Assuming the proportion of successful completion of LipiFlow treatment is 95%, with n= 
50 eyes, a two-sided 95% confidence interval will be (89%, 100%), i.e., a precision of 
6.0%.

 
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APPENDIX B  EQUIPMENT LIST 
The following equipment will be supplied to an investigative site for the duration of the study 
provided that the site does not already have such equipment available for use.  This equipment 
loan will be documented in the Equipment Use Agreement or Clinical Trial Agreement, which 
indicates that the equipment is to be returned to JJSV at the completion of the study. 
• LipiFlow Activator LFD-2100 (investigational device) 
• LipiFlow Instructions for Use (IFU) including the Quick Start Guide (if needed) 
• LipiFlow Consoles (if needed) 
• Semi-permanent Cable (if needed) 
• Meibomian Gland Evaluator (MGE) (if needed) 
• Lid Stabilizer Tape (if needed) 
• Commercially-available standard fluorescein strips (if needed) 
• Commercially-available standard lissamine green dye (if needed) 
• Color printer (if needed) 

 
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APPENDIX C  SUMMARY OF PROCEDRUES REQUIRED AT EACH VISIT 
Examination 
Pre-treatment Visit 
Treatment Visit 
(may happen on 
the same day of 
Pre-treatment visit) 
Informed consent 
X 
 
Screening and Enrollment: including but not limited 
to reviewing medical and ocular history, discussing 
study eligibility etc. 
X 
 
Biomicroscopic slit-lamp exam 
Xa 
Xa, b 
Meibomian gland assessment (optional, upon 
investigator’s discretion) 
Xc 
 
Ocular surface staining 
Xa 
Xb 
Non-dilated fundus exam 
X 
 
LipiFlow Treatment with Activators LFD-2100 
 
X 
Investigator Questionnaire for LipiFlow treatment 
with Activator LFD-2100 
 
X 
a Pre-treatment exams. (If the Treatment Visit doesn’t happen on the same day of the Pre-reatment Visit, 
a biomicroscopic slit-lamp exam must be performed before LipiFlow treatment performed at the 
Treatment visit to assess the findings for the presence of any medical findings.) 
b Post-treatment exams. 
c Note: MGD diagnosis can be based on prior medical records, investigator opinion. or based on 
assessment of meibomian glands of the lower eyelid.  The need for meibomian gland assessment is at 
the investigator’s discretion.  
  
 

 
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APPENDIX D  SLIT-LAMP EVALUATION 
The Investigators or designees shall evaluate the eyelids, palpebral and bulbar conjunctiva, 
cornea, anterior chamber, iris and lens using a slit lamp biomicroscope.  The Investigator or 
designee everts the upper eyelid to evaluate the upper palpebral conjunctiva.  Corneal or 
conjunctival staining may be conducted as necessary at the discretion of the investigator.  The 
Investigator or designee assesses the findings for the presence of any medical findings. 
A)  Ratings of Conjunctival Injection 
Assess the ocular vascular response via external examination.  Specifically, classify the 
appearance of injected (dilated) blood vessels within the limbus as well as within the bulbar 
conjunctiva.  Observe limbal region and bulbar conjunctiva with the slit lamp at 5X - 12X. 
Amount 
Grade 
Description 
None 
0 
No injection present. 
Trace 
1 
Slight limbal (mild segmented), bulbar (mild regional), and/or 
palpebral injection. 
Mild 
2 
Mild limbal (mild circumcorneal), bulbar (mild diffuse), and/or 
palpebral injection. 
Moderate 
3 
Significant limbal (marked segmented), bulbar (marked regional or 
diffuse), or palpebral injection. 
Severe 
4 
Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or 
scleral), or palpebral injection. 
B)  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the number of 
microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
1 
a. Barely discernable localized epithelial or sub-epithelial haziness, 
and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernable localized stromal cloudiness 
Mild 
2 
a. Faint but definite localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 

 
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Amount 
Grade 
Description 
Moderate 
3 
a. Significant localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
4 
a. Definite widespread epithelial or stromal cloudiness, giving dull 
glass appearance to cornea or numerous coalescent bullae 
(please note the number and location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of striae 
or folds) 
C)  Medical Findings of Other Ocular Surface and Eyelid Irritation or Inflammation 
Carry out a full biomicroscopic examination.  Corneal or conjunctival staining may be conducted 
as necessary at the discretion of the investigator.  Record and grade by severity the slit lamp 
findings that cannot be classified as conjunctival injection and corneal edema.  Examples 
include but are not limited to: corneal abrasion, conjunctival edema, eyelid edema, bruising, 
blood blister, dermatitis, hordeolum or chalazion. 
Amount 
Grade 
Description 
None 
0 
No other significant biomicroscopic findings. 
Trace 
1 
Minimal findings such as tear film abnormality (debris or low tear 
break up time), ocular tearing. 
Mild 
2 
Mild findings, such as few corneal faint infiltrates, eyelid edema, 
sensitivity to light. 
Moderate 
3 
Significant findings, such as: eyelid inflammation (e.g. 
blepharochalasis, blepharitis), eyelid dermatitis, chalazion, 
meibomitis, corneal infiltrates (multiple or dense), conjunctivitis, 
conjunctival abrasion, epidemic keratoconjunctivitis. 
Severe 
4 
Severe findings, such as: iritis with marked cells and/or flare, 
corneal or conjunctival infection, corneal ulcer, recurrent erosion. 
 

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 Version 3.0  / Aug/31/2020                                                             39                                                       PR/DRYE-105-ACTS 
 
There are approximately 20 to 30 meibomian glands along the lower eyelid.  The Investigator or 
designee assesses 15 glands located temporally, centrally and nasally, as shown in Figure 2. 
The central region of the Meibomian Gland Evaluator should be carefully placed in the temporal, 
central and nasal regions as described in this procedure to avoid overlap in the gland 
assessment.   
 
 
The following procedure is used for examination and grading of meibomian gland function. 
1. Under the slit-lamp biomicroscope 10x to 16x magnification, locate the temporal region of 
the lower eyelid and observe 5 consecutive glands orifices in this region. 
2. Holding the Meibomian Gland Evaluator between the forefinger and the thumb, place the 
instrument contact surface onto the skin immediately below the lash line of the lower eyelid 
so that the long dimension is parallel to the eyelid margin, and the five glands are in the 
central region of the Meibomian Gland Evaluator. 
3. Once full contact is achieved between the Meibomian Gland Evaluator contact surface and 
the outer skin of the lower eyelid, rotate the shaft of the Meibomian Gland Evaluator 
downward approximately 15 to 45 degrees so that it is tangential to the eyeball.  
4. Depress the Meibomian Gland Evaluator to exert a constant force over the meibomian 
glands. Adjust the position of the Meibomian Gland Evaluator to cause the flat surface of the 
lower eyelid margin to roll slightly outward, facilitating a clear view of the meibomian gland 
orifices.  
5. To facilitate observation of the gland secretions, gently wipe the gland orifices along the 
eyelid margin clean with a dry cotton swab immediately after applying pressure while 
maintaining the Meibomian Gland Evaluator in position and maintaining pressure. 
Figure 2:  Location of Lower Eyelid Meibomian Glands for Assessment 

 
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6. Hold the Meibomian Gland Evaluator in place over the meibomian glands for a minimum of 
10 and a maximum of 15 seconds while evaluating the secretion characteristics from each 
meibomian gland. The expressed secretion from each gland is graded according to the 
characteristics displayed in Table 1. 
 
Table 1:  Meibomian Gland Assessment Secretion Grading Scale 
Grade 
Secretion Characteristics 
3 
Clear liquid oil secretion 
 
 
 
2 
Colored/cloudy liquid secretion 
1 
Inspissated (toothpaste-consistency) secretion 
0 
No secretion (includes capped orifices) 

 
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APPENDIX F   INSTRUCTIONS FOR OCULAR SURFACE STAINING  
CORNEAL STAINING  
The Investigator or designee assesses the corneal staining after instillation of fluorescein dye in 
the eye using the following method. 
1. Place one drop of commercially available saline on a standard fluorescein strip.  Take care 
to avoid applying the saline to the fluorescein strip holder. Do not shake the strip. Wait ten 
seconds after application of the saline before proceeding.  
2. Instruct the patient to look down and towards the opposite hand from the eye receiving the 
stain. It may be helpful to ask the subject to fixate on his/her own thumb. Place the subject’s 
thumb to rest on the opposite leg to achieve inferior fixation of approximately 45 degrees 
down and 20 degrees nasal.  
3. Retract the upper eyelid. Introduce the fluorescein strip at an approximate 30-degree angle 
and touch the superior temporal bulbar conjunctiva, preferably 4 mm or more from the 
limbus, for 2 seconds, so that 1-2 mm of the flat side makes contact with the ocular surface. 
Withdraw the strip and release the upper lid.  
NOTE: If the size of the strip prevents application to the desired position on the superior 
temporal bulbar conjunctiva, apply the strip to a location on the bulbar conjunctiva 
as close as possible to the preferred position.  
4. Instruct the subject to close the eyelids completely three times.  Wait 1.5 minutes (90 
seconds) before evaluating the ocular surface for staining. 
5. To observe the fluorescein staining, evaluate the subject’s eye under the slit-lamp 
biomicroscope using a cobalt blue filter transmitting 330 to 400 nm and a beam 
approximately 4 mm wide and l0 mm high.  
6. Examine the entire cornea. Grade the corneal staining observed in the central, inferior, 
nasal, temporal and superior regions as shown in Figure 4 on a scale of 0 to 3 based on the 
Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye.  
Document the staining grade. 
 
 
 
Figure 4:  Diagram of Corneal Regions for Fluorescein Staining Grading 

 
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CONJUNCTIVAL STAINING  
The Investigator or designee assesses the conjunctival staining after instillation of lissamine green 
dye in the eye using the following method.  
1. Place one drop of commercially available saline on a standard lissamine green strip.  Take 
care to avoid applying the saline to the strip holder. Do not shake the strip. Wait ten seconds 
after application of the saline before proceeding.  
2. Instruct the patient to look down and towards the opposite hand from the eye receiving the 
stain. It may be helpful to ask the subject to fixate on his/her own thumb. Place the subject’s 
thumb to rest on the opposite leg to achieve inferior fixation of approximately 45 degrees 
down and 20 degrees nasal.  
3. Retract the upper eyelid. Introduce the strip at an approximate 30-degree angle and touch 
the superior temporal bulbar conjunctiva, preferably 4 mm or more from the limbus, for 2 
seconds, so that 1-2 mm of the flat side makes contact with the ocular surface. Withdraw the 
strip and release the upper lid.  
NOTE: If the size of the strip prevents application to the desired position on the superior 
temporal bulbar conjunctiva, apply the strip to a location on the bulbar conjunctiva 
as close as possible to the preferred position.  
4. Instruct the subject to close the eyelids completely three times.  Wait 1.5 minutes (90 
seconds) before evaluating the ocular surface for staining. 
5. To observe the lissamine green staining, evaluate the subject’s eye under the slit-lamp 
biomicroscope with a beam approximately 4 mm wide and l0 mm high.  
6. Examine the entire bulbar conjunctiva. Grade the conjunctival staining observed in the six 
regions as shown in Figure 5 on a scale of 0 to 3 based on the Report of the National Eye 
Institute/Industry Workshop on Clinical Trials in Dry Eye. Document the staining grade. 
 
 Figure 5:  Diagram of Conjunctival Regions for Lissamine Green Staining Grading 
 
 

 
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APPENDIX G. ADVERSE EVENT AND COMPLAINT REPORTING INSTRUCTIONS 
All adverse events and complaints related to using JJSV products must be reported to JJSV.   
All adverse events and complaints: 
For events that are not considered serious or related to the study device: 
1. Record the event and/or complaint on the case report form that corresponds to the visit 
during which awareness of the event occurred.  Additionally, a complaint may be 
reported via a telephone call to JJSV. 
2. Complete the case report form (CRF) in a timely manner. 
Serious Adverse Events or device deficiencies that may have led to a serious event 
In the event of a serious event (i.e., life- or sight-threatening incident) whether or not related to 
the device, or a device deficiency that may have led to a serious event, the investigator shall: 
1. Notify JJSV immediately (no more than 24 hours after learning of the event) as 
follows:  
a. Contact the following JJSV personnel by phone and/or email: 
               
               
 
 
  
b. Complete an Adverse Event Form and submit to JJSV  
 
Non-serious, device-related Events: 
For events that are not considered serious but are believed related to the study device (ADEs): 
1. Complete an Adverse Event Form 
2. Ensure the data are submitted to JJSV within a timely manner.