Tear Film Innovations iLux Safety Study
Phase: NA
Conditions: Meibomian Gland Dysfunction, Evaporative Dry Eye
Sponsor: Tear Film Innovations, Inc.



Table of Contents 
PROTOCOL SUMMARY ........................................................................................................ 5 
1 
BACKGROUND AND INTRODUCTION ......................................................... 9 
1.1 
INDICATION FOR USE............................................................................ 9 
1.2 
ILUX SYSTEM............................................................................................... 9 
2 
STUDY DESIGN ................................................................................................. 10 
2.1 
OBJECTIVE................................................................................................. 10 
2.2 
DESCRIPTION OF THE STUDY...................................................................... 10 
2.3 
OUTCOME MEASURES................................................................................ 11 
2.4 
STUDY POPULATION .................................................................................. 11 
3 
STUDY TREATMENTS .................................................................................... 12 
3.1 
INVESTIGATIONAL TREATMENT ..................................................... 12 
3.2 
POST- TREATMENT DETAILS:............................................................ 13 
4 
STUDY PROCEDURES ..................................................................................... 13 
4.1 
INFORMED CONSENT.................................................................................. 13 
4.2 
ASSIGNMENT OF SUBJECT IDENTIFICATION................................................ 14 
4.3 
SCHEDULE OF STUDY ASSESSMENTS ......................................................... 14 
5 
SAFETY PARAMETERS .................................................................................. 15 
5.1 
DEFINITION OF ADVERSE EVENTS.............................................................. 15 
5.2 
DEFINITION OF SERIOUS ADVERSE EVENT................................................. 15 
5.3 
ADVERSE EVENT ASSESSMENT AND DOCUMENTATION ............................. 15 
5.3.1 Classification of Adverse Events by Intensity/Severity.................16 
5.3.2 Expectedness..................................................................................16 
5.3.3 Relatedness ....................................................................................16 
5.3.4 Treatment or Action Taken............................................................17 
5.3.5 Outcome.........................................................................................17 
5.4 
RISK ANALYSIS & ANTICIPATED ADVERSE EVENTS.................................. 17 
5.4.1 Risk Analysis .................................................................................17 
5.4.2 Anticipated Adverse Events...........................................................18 
5.5 
SERIOUS ADVERSE EVENT AND UNANTICIPATED ADVERSE DEVICE EFFECT 
REPORTING ................................................................................................ 19 
6 
STUDY DISCONTINUATION ......................................................................... 19 
7 
STATISTICAL PLAN ........................................................................................ 19 
7.1 
EFFICACY ENDPOINTS................................................................................ 20 
7.2 
SAMPLE SIZE JUSTIFICATION ..................................................................... 20 
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7.3 
SAFETY ...................................................................................................... 20 
8 
RECORD RETENTION .................................................................................... 20 
9 
STUDY MONITORING REQUIREMENTS ................................................... 20 
10 
PROTOCOL DEVIATIONS/AMENDMENTS ............................................... 20 
 
 
 
 
 
 
 
 
 
 
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PROTOCOL SUMMARY 
Protocol 
Number 
2020-02, Version 1.0
Title
iLux Safety Study
Sponsor
Tear Film Innovations, Inc.
Regulatory 
Status
Non-Significant Risk Investigational Device Study
Objective
The objective of this study is to measure the 
temperature of
the cornea and surrounding eye tissue temperature immediately after 
heating the eyelids with the iLux device using the protocol treatment 
profile.
Study Design
Prospective, non-randomized, open label, trial
Number of 
Centers
1
Investigational 
Device
iLux 2020 System
Page 22 of 65

1
BACKGROUND AND INTRODUCTION 
Meibomian glands are located in the tarsal plate of the upper and lower eyelids, where they 
terminate along the interior rim (or margin) of the eyelids.  These glands secrete meibum, 
which is a lipid-rich essential component of a healthy tear film. When sufficient meibum 
is not present in the tear film, the aqueous layer of the tear film is disrupted and readily 
evaporates causing irritation, redness, and inflammation of the lid margin and surrounding 
tissues.  Meibomian Gland Dysfunction (MGD) is associated with a failure of these glands 
to produce adequate quantities of meibum due to atrophy, inflammation, or obstruction, 
and is thought to be the most common cause of evaporative dry eye disease (EDE)1.
Recommended methods for diagnosis of MGD reported in the literature2 includes 
evaluation of meibomian gland expressibility by applying digital pressure and observing 
gland response with a slit-lamp microscope.
1.1
INDICATION FOR USE 
The iLux System is indicated for the application of localized heat and pressure therapy in 
adult patients with chronic cystic conditions of the eyelids, including meibomian gland 
dysfunction (MGD), also known as evaporative dry eye. 
1.2
ILUX SYSTEM 
The iLux system enables an eye care professional to apply a treatment to unclog blocked 
glands by heating the lids to melt the meibum while applying enough compression to the 
lid to unblock clogged glands. By unclogging the glands, the glands can resume providing 
lipids to the tear film, which is key to preventing the aqueous (tear) layer from evaporating.
Clogged and unproductive meibomian glands lead to increase evaporation of the aqueous 
layer of the tears leading to inflammation and eventually atrophy of the meibomian glands.  
It is not known if an atrophied gland can be “revived”, therefore it is important to maintain 
the health and viability of the existing meibomian glands. The iLux treatment is designed 
to unclogged meibomian glands thereby maintaining the health of the gland and the ocular 
surface. 
The main components of the iLux system include a disposable tip section and a handheld 
battery-powered instrument.  The disposable tip section is a sterile, single-use device that 
snaps onto the tip of the instrument.  It has a thin back plate that slides underneath the 
eyelid, and a front plate that is pushed against the front surface of the eyelid.  All materials 
that contact the patient are made from biocompatible silicone.  The instrument portion has 
a high-quality magnifying lens that allows the clinician to view the eyelid margin 
throughout the procedure.  There is also a compression control switch, when pressed, 
advances the front plate against the patient’s eyelid.
1 Schaumberg, D.K. et al.  The International Workshop on Meibomian Gland Dysfunction: Report of the 
Subcommittee on Epidemiology of, and Associated Risk Factors for MGD, Investigative Ophthalmology 
and Visual Science, Special Issue 2011, Vol. 52, No. 4, pp 1994-2005.
2 Tomlinson, A et al.  The International Workshop on Meibomian Gland Dysfunction: Report of the 
Diagnosis Subcommittee, Investigative Ophthalmology and Visual Science, Special Issue 2011, Vol. 52, 
No. 4, pp 2006-2049.
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To treat clogged glands, the clinician presses the heating switch (located on the 
compression control switch) to turn on the energy source and warm the eyelid tissue.  The 
inner eyelid temperature is displayed on the instrument, enabling the clinician to titrate the 
ideal amount of heating and compression to optimize unclogging of the blocked glands.
The handheld device includes circuitry with a heat safety limit of 44°C so the inside of 
the back plate that contacts the inner part of the eyelid and the front plate that contacts the 
outer part of the eyelid cannot go above this safe temperature.
The iLux system was used recently on 30 subjects in an IRB-approved non-significant 
risk study in the United States with no adverse events reported. 
2
STUDY DESIGN 
2.1
OBJECTIVE 
The objective of this study is to measure the
temperature of the cornea and 
surrounding eye tissue temperature immediately after heating the eyelids with the iLux 
device using the protocol treatment profile.  
2.2
DESCRIPTION OF THE STUDY 
Up to 15 eligible subjects will be enrolled at 1 clinical site.
The primary effectiveness analysis shall be based on immediate post-heating assessments.  
The clinical parameters outlined in Appendix 1 shall be evaluated for each eye treated with 
the iLux device per the schedule outlined.
1. Discomfort/pain during, and after treatment – A subjective pain scale shall be used.  
A subjective report of discomfort shall be recorded on a scale of from 0-10.
Descriptive Anchors on the scale include: 0 = no discomfort or pain, 2 = slight or 
transient awareness of pressure without pain, 4 = moderate discomfort with minimal 
pain, 6 = moderate pain, 8 = severe pain, 10 = intolerable pain.  In an effort to provide 
some level of consistency to the subjective discomfort report, a scale shall be provided 
for the subject to compare their level of discomfort to commonly experienced episodes 
of discomfort in every-day life (see Table 1 below).
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x
Event diagnosis
x
Intensity or severity
x
Expectedness
x
Relatedness to study treatment
x
Treatment or action taken.
x
Outcome
Whenever possible, recognized medical terms should be used when recording AEs.
Colloquialisms and/or abbreviations should not be used. Only one medical concept, 
preferably a diagnosis instead of individual symptoms, shall be recorded as the event.
If more than one distinct adverse event occurs, each event shall be recorded separately.
5.3.1
Classification of Adverse Events by Intensity/Severity 
All adverse events shall be graded on a three-point scale (mild, moderate, severe) for 
intensity/severity, defined as a qualitative assessment of the level of discomfort of an 
adverse event as is determined by the Investigator or reported to him/her by the subject.  
The assessment of intensity is made irrespective of study procedure relationship or 
seriousness of the event and shall be evaluated according to the following scale:
Mild: 
Awareness of sign or symptom, but easily tolerated.
Moderate: 
Discomfort enough to cause interference with usual activity.
Severe: 
Incapacitating with inability to work or do usual activity.
There is a distinction between the severity and the seriousness of an adverse event. Severity 
is a measurement of intensity; thus, a severe reaction is not necessarily a SAE.
5.3.2
Expectedness 
All AEs shall be evaluated as to whether they are expected or unexpected.
Expected (anticipated):
An adverse event is expected when the nature, 
severity, or degree of incidence was previously 
described, including those events listed in section 
5.4.2.
Unexpected (unanticipated):
An adverse event is unexpected when the nature, 
severity, or degree of incidence was not 
previously described.
5.3.3
Relatedness 
The study investigator shall evaluate if the AE is related to the iLux heating.  Relationship 
is defined in the following manner:
Not related: 
The event is clearly related to other factors such as subject’s 
clinical state, therapeutic interventions, concomitant disease or 
therapy administered to the subject, and does not follow a 
known response pattern to the procedure.
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Related: 
The event follows a reasonable, temporal sequence from the 
time of procedure and/or follows a known response pattern 
to the study procedure and cannot be reasonably explained 
by other factors such as subject’s clinical state, therapeutic 
interventions, or concomitant therapy administered to the 
subject.
5.3.4
Treatment or Action Taken 
Action taken in response to an adverse event shall be recorded as:
x
None
x
OTC or Rx drug added
x
Non-drug treatment/procedure
x
Hospitalization or ER visit
Action taken with study procedure shall be recorded as:
x None
x Study procedure interrupted
x Study procedure discontinued
5.3.5
Outcome 
The clinical outcome of an AE shall be characterized as follows:
x
Resolved without sequelae
x
Resolved with sequelae (specify)
x
Ongoing (i.e. continuing at time of study discontinuation)
x
Death
x
Unknown
5.4
RISK ANALYSIS & ANTICIPATED ADVERSE EVENTS 
5.4.1
Risk Analysis 
Risks associated with using the iLux 2020 were assessed in accordance with ISO 14971, 
which is an international standard for medical device risk management that is recognized 
by the FDA.  Most of the potential hazards identified in the analysis are common to many 
medical devices and are addressed by compliance with international standards. Other 
potential hazards unique to the iLux were addressed by assessing risk using Failure Modes 
Effects and Criticality Analysis (FMECA) and identifying controls to reduce residual risks 
to acceptable levels. 
The iLux is used in the eye and the sterile disposable may come in contact with the 
conjunctiva and or cornea during the treatment of each lid.  The sterile disposable is 
covered with a biocompatible silicone similar to a contact lens.  There is nothing implanted 
either temporarily or permanently in the eye related to the iLux and the risk is similar to 
other meibomian gland treatments.  Testing demonstrated that the disposable meets the 
requirements for biocompatibility (ISO 10993) and sterilization and packaging (ISO 1135, 
ISO 11607).  
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Compliance to IEC 60601-1, which is an international standard for safety of electromedical 
devices, was evaluated by the nationally recognized test laboratory, Nemko.  As part of the 
evaluation, the risk management files were reviewed to verify compliance with ISO 14971. 
Other IEC 60601-1 tests included electromagnetic compatibility (IEC 60101-1-2) and 
optical radiation safety (IEC 62471).  The iLux system successfully met the requirements 
of all tests performed.
The instrument warms the eyelids using optical radiation (i.e., light) at two wavelengths, 
lime-green and infrared.  Potential photobiological hazards were evaluated by David 
Sliney, PhD, who is an internationally-respected expert in the field of optical radiation 
hazards and consults frequently with both the FDA and industry.  His testing was also 
witnessed by an expert from Nemko for certification to the standard IEC 62471.  Their 
analysis concluded that the iLux system poses minimal risk for damage to the eye or skin 
and can be classified as exempt from warnings.  To further reduce risk, the heating cannot 
be operated without a disposable attached, which blocks a significant portion of the emitted 
light.
A safety study was conducted at Absorption Systems in San Diego from November to 
December, 2014.  The study involved exposing one shaved eyelid on each of four New 
Zealand white rabbits to the same energy wavelengths and levels that are emitted by the 
iLux device, using a back plate and front plate similar to the human device, and applying 
a controlled force to the eyelids.  One cohort received two-minute treatments and the other 
received four-minute treatments, with each treatment applied once per week for five 
treatments.  No adverse events occurred and there were no changes observed in the eyelids 
or eyes, and there were no adverse histological findings. 
The iLux system measures temperatures on the inner and outer surfaces of the eyelid.  Four 
redundant temperature sensors are included in the disposable.  The instrument displays the 
highest inner eyelid temperature.  If any of the four sensor readings exceeds 44 °C, the 
instrument automatically turns off the heat source. Bench top testing has shown that the 
back plate of the iLux disposable tip does not heat above 40°C.
Lastly, the iLux system was recently used on 30 subjects in an IRB approved, non-
significant risk study in the United States with no adverse events. 
The mitigations taken demonstrate that the risk of any adverse effects on study subjects 
participating in this study have been eliminated or minimized to the extent possible and 
therefore, the risk to study subjects is acceptable for this study.
5.4.2
Anticipated Adverse Events 
x
Eyelid/eye Pain
x
Eyelid Irritation or Inflammation
x
Ocular Surface Irritation or Inflammation
x
Ocular Symptoms – Burning, stinging, tearing, itching, discharge, redness, foreign 
body sensation, visual disturbance, sensitivity to light.
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7.1
EFFICACY ENDPOINTS 
The primary efficacy endpoint of this trial is the
temperature of the cornea and 
the surrounding eye tissue 
 after heating with the iLux instrument.
7.2
SAMPLE SIZE JUSTIFICATION 
A sample size of 15 subjects (30 eyes) has been chosen for an initial assessment of the 
safety of the iLux System in this patient population. This number was chosen to provide 
sufficient data to make an initial safety determination of the System while minimizing the 
number of patients subjected to a clinical trial.
7.3
SAFETY 
AEs, SAEs, and other findings shall be summarized by presenting the number and
percentages of subjects with each event. Continuous endpoints shall be summarized using 
summary statistics such as means, medians, standard deviations, minima, maxima, and 
relevant percentiles.
8
RECORD RETENTION 
The investigator shall maintain all subject records for a period of two years after the 
investigation is discontinued and FDA is notified.
The investigator must maintain accurate records of the receipt of all investigational 
material shipped by the sponsor, including the date and lot numbers received. In addition, 
accurate records must be kept on the amount and date that the investigational material, by 
lot number, was used and for each subject.
The investigator must assure that study supplies are used only in conjunction with subjects
enrolled in the study and under the direct supervision of the investigator or co-investigators.
9
STUDY MONITORING REQUIREMENTS 
It is the responsibility of the study sponsor, Tear Film Innovations, Inc., to ensure proper 
monitoring of the investigation and to see that all the clinical requirements are met. Either 
Tear Film personnel or a contracted third party will perform monitoring.
In general, 
monitoring will consist of an initiation visit to train the site on the proper use of the device 
and execution of the protocol.  Due to the small size of the study and the limited data being 
collected, monitoring will likely consist of 1-2 visits to the site to compare study CRF data 
with site source data.  During these visits, the monitor may review the subject records to 
verify that all records and files are current and to assure compliance with all requirements 
of this protocol.  The final monitoring visit may also serve as the study close-out visit.
10 PROTOCOL DEVIATIONS/AMENDMENTS 
An investigator may deviate from the protocol to protect the life or physical well-being of 
a subject in an emergency, and must notify the sponsor and the reviewing IRB within 5 
working days after the emergency occurred.  Except in such an emergency, an investigator 
may not deviate from the protocol unless he/she obtains the prior approval of Tear Film 
Page 37 of 65

Innovations, Inc.  Depending on the specifics of the deviation, IRB approval may also be 
required.
 
Page 38 of 65

APPENDIX 1: SCHEDULE OF ASSESSMENTS
ASSESSMENT 
PRE-
TREATMENT 
TREATMENT 
POST- 
TREATMENT 
FOLLOW UP 
Treatment Window
Day 0
Day 0
Day 0
Day 1 (-0/+3 
days)
Informed Consent
X
Demographics/medical/ocular history
X
Visual Acuity
X
X
Slit Lamp for Anterior Segment health
X
X
Lid Margin Abnormalities
X
X
Corneal fluorescein staining slit lamp evaluation
X
X
Intraocular pressure
X
X
Cornea and surrounding eye tissue temperature
X
X
iLux heating
X
Discomfort/pain questionnaire
X
X
X
Adverse Events
X
X
X
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APPENDIX 2: ILUX USER MANUAL 
APPENDIX 3: CORNEAL FLUORESCEIN STAINING PROTOCOL 
APPENDIX 4: GENERAL MEDICAL AND OPHTHALMIC HISTORY  
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Page 41 of 65

Appendix 2: Case Report Forms
Page 43 of 65

PROTOCOL 2020-02
CRF v2016-04-23
SUBJECT ID: ______-_______
Were you able to turn the iLux Device On and Off?
  Yes   No  
Were you able to read the screen on the iLux clearly without difficulty? 
  Yes   No  
Were you able to remove the disposable from the packaging and load the disposable into the device as 
instructed by the User’s manual? 
  Yes   No  
Were you able to apply pressure to the eyelid without difficulty?
  Yes   No  
Were you able to apply heat to the eyelid without difficulty?
  Yes   No  
Were you able to view the eyelid margin with the magnifier without difficulty? 
  Yes   No  
Were you able to recharge the battery as described in the User’s manual?
  Yes   No  
For an answer of "No" above, please provide additional details below:
FORM 7: iLux USABILITY ASSESSMENT - Page 1 of 1
                           Investigator Signature:
_______________________________
Date: _____-________-_______
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Appendix 3: Informed Consent Form
Page 54 of 65

INFORMED CONSENT TO PARTICIPATE IN CLINICAL RESEARCH STUDY
iLux™ Safety Study
Sponsor: 
 
 
 
Tear Film Innovations, Inc. 
  
 
 
 
 
Protocol Number:  
 
2020-02
Principal Investigator: 
 
James Owen, O.D.  
 
 
 
 
 
Encinitas Optometry
 
 
 
 
 
681 Encinitas Blvd., #302
 
 
 
 
 
Encinitas, CA  92924 
 
 
24-Hour Telephone Number:   (760) 436-1877
This is a research study. This study includes only individuals who voluntarily choose to 
participate. Please take your time to make your decision. Discuss it in confidence with your 
regular doctor, friends and family if you want.  Be sure to ask questions about anything you do
not understand in this document. Taking part in a research study is entirely voluntary and you 
can stop being in the study at any time you want to, without any penalty or impact on your 
medical care or benefits.
The reason we are doing this research study is to gather information. In this document, you will 
see the term “treatment.” This term is used in research studies and is not meant to indicate 
that you will be receiving medical treatment for your condition as the device being used in this 
investigational study is experimental.
WHAT IS THIS STUDY ABOUT?
The purpose of this study is to measure corneal temperature as well as the surrounding eye 
tissue temperature including the eye lids after heating the eyelids with the iLux device after 
treatment with the iLux™ device. Bench top safety testing has shown that the back plate of the 
iLux disposable tip does not heat above the safe temperature of 40°C (104°F). The study 
device is investigational, which means that it is not approved by the Food and Drug 
Administration (FDA).
If you participate in this study, you will be receiving one treatment with the iLux device.  
HOW LONG IS THIS STUDY? HOW MANY OTHER PEOPLE WILL BE IN THIS STUDY? 
About 15 adults with healthy eyes will take part in this study. You will be in the study for about
one week, including a screening evaluation, a single treatment and a follow up evaluation one 
day after the treatment visit. 
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WHAT IF NEW INFORMATION BECOMES AVAILABLE?
If new information in relation to the study DEVICE becomes available, that may be relevant to 
the purpose and safety of the study and your willingness to continue participation in this study, 
you will be informed by the study doctor.
WHAT WILL HAPPEN DURING THE STUDY?
If you agree to take part in this research study, you will be required to sign this informed 
consent form before any procedures take place.  
STUDY PROCEDURES:
During the screening and if you qualify and continue, during the study the following procedures 
will occur:
x
Demographics/medical/ocular history
x
Visual acuity (a test to evaluate your vision)
x
Slit lamp evaluation for anterior segment health (an exam allowing the doctor to see the 
front of the eye)
x
Evaluation of any eyelid margin abnormalities
x
Corneal fluorescein staining slit lamp evaluation (a variation of the slit lamp exam that 
allows for the doctor to see abrasions and scarring on the eye)
x
Intraocular pressure (an exam to assess the fluid pressure inside the eye)
x
iLux™ treatment
The study doctor will talk to you and give you a list of the things you must do to participate, 
such as:
  
x
Your history of contact lens wear in the last 30 days and intention on wearing contact 
lenses during this study.
You may have additional tests, for example, to follow up on tests previously done.
Please tell your regular health care providers and any emergency care providers that you are 
participating in this research study.
At the screening visit, your eyes will be examined and you will be asked questions about your 
health to make sure that you meet the requirements to participate in the study without 
unacceptable risk to your safety and health. If it is found that you do meet those requirements, 
you will have a detailed eye exam including the assessments included in the above list. The 
iLux device will then be used on your eyelids for a single treatment. The device is a small 
instrument that the study doctor will hold in their hand. You will have eye drops with numbing 
medicine dripped into your eye to keep the eye surfaces numb during the treatment (the 
effects of these eye drops will wear off in 10-20 minutes after the procedure). The study doctor 
will gently pull your eyelid away from the eyeball and place the eyelid between two pads on the 
device then gently squeeze the eyelid between the pads. 
Page 56 of 65

The study doctor will then push a button on the device that activates a green light and some 
infrared (warming lights) on the eyelids for 90 seconds. The light will warm the eyelids to 
between 104 and 107.5 degrees Fahrenheit. The study doctor will also look through a 
magnifying lens on the device to get it into the proper place on your eyelids.
The device is designed to shut off automatically if you eyelids get too hot. It is also designed 
NOT to touch your eyeball. However, if it accidentally did touch your eyeball, the device will be 
cool enough that you eyeball is not warmed higher than your normal body temperature. This 
helps prevent any risk of damage to you eye. 
You will be asked to answer questions about whether you are having any eye discomfort on 
the day of the procedure or the next day.
After the one day follow up phone call, your participation in the study will end. 
WHAT ARE THE RISKS AND DISCOMFORTS OF PARTICIPATING IN THIS STUDY?
The iLux™ is used in the eye and the sterile disposable may come in contact with the 
conjunctiva and or cornea during the treatment of each lid.  The sterile disposable silicone 
pads are covered with a biocompatible silicone similar to a contact lens.  There is nothing 
implanted either temporarily or permanently in the eye related to the iLux™.
David Sliney, PhD, a nationally-respected expert in the field of ocular radiation hazard who 
consults frequently with both the FDA and industry, performed an on-site evaluation of Tear 
Film’s benchtop system.  He concluded that the iLux™ system conforms to applicable safety 
standards.
The iLux has also undergone safety testing by NEMKO and has passed all test which were 
based on international standards.   
An animal safety study was conducted at Absorption Systems in San Diego from November to 
December, 2014.  No adverse events occurred and there were no changes observed in the 
eyelids or eyes, and there were no adverse histological findings. 
Anticipated risks include: Eyelid/eye pain (during and after procedure), eyelid irritation or 
inflammation, ocular surface irritation or inflammation and ocular symptoms (stinging, tearing, 
itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light). 
There may be risks to being in this study that we cannot predict.  
You should discuss these risks with the study doctor and/or your regular doctor. 
Side effects occurring during the trial can be treated by the study doctor, if this is deemed 
necessary. It is important that you inform the study doctor any unusual or unpleasant effects 
which you should feel.
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Are there pregnancy risks? 
While it is not expected that the study device will pose risk to an unborn baby, no information 
about possible risk is available. You cannot participate in this study if you are pregnant or 
nursing a baby. If you think you are pregnant during the study, you must tell the study doctor 
immediately.
If you are a male, you should not father a baby or be a sperm donor while in this study.
For more information about risks and side effects, ask the study doctor.  
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Subjects participating in this study may or may not benefit from the study device. If you agree 
to take part in this study, there may or may not be direct medical benefit to you. Information 
learned from this study may benefit others in the future.
WHAT, IF ANY, ARE THE ALTERNATIVES TO PARTICIPATING IN THIS STUDY?
This study is not designed to diagnose, treat or prevent any disease. Your alternative is to not 
participate.
CONFIDENTIALITY
Your personal information will be kept confidential to the extent permitted by law. We cannot 
guarantee absolute confidentiality. By signing this document, you give permission to access 
your medical records, including after withdrawal, for data verification purposes.
Organizations that may inspect and/or copy your research records for quality assurance and 
data analysis include groups such as:
x
The study staff and other researchers involved in the study
x
Tear Film Innovations, Inc., (Sponsor of this study) or those who work for or represent 
the Sponsor
x
The U.S. Food and Drug Administration (FDA)
x
Aspire Independent Review Board (IRB) 
The results from the study may be published for scientific purposes, but your identity will be 
kept confidential.
In the rare event that your information is required to be disclosed by law to another entity, 
privacy laws may not apply, and neither the Sponsor nor Aspire IRB can protect your 
information.
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WHAT ARE THE COSTS? 
There are no additional costs associated with being in this study. You are responsible for your 
regular health care while in this study. You will not have to pay for the device during study 
visits, or tests/procedures that are part of the study.  
INVESTIGATOR PAYMENT                                       
The Sponsor is paying the study doctor and the study site for conducting this study.
WILL YOU BE COMPENSATED DURING THE STUDY?
You will be compensated for participating in and completing this research study. If you 
complete the study, you will receive $100. This amount is prorated as follows:
x
$100 for the screening/treatment visit
This money is meant to compensate your travel expenses, lost wages from work, child care, 
etc. that you may have as a result of participating in this study.
WHAT HAPPENS IF YOU HAVE COMPLICATIONS OR ARE INJURED?
If you have serious side effects, complications or are injured because of participating in this 
study, please contact the study doctor promptly.  The study doctor will provide any necessary 
medical treatment to help you promptly recover from the injury.  Your insurance will be billed 
for the medical treatment and the study Sponsor will pay for the costs not covered by your 
insurance or by third party governmental programs. Such reimbursement will be offered only 
for reasonable costs and only if the Study Device has been used in accordance with the 
Protocol and any other instructions provided by the Sponsor.  
YOUR RIGHTS AS A RESEARCH SUBJECT
Taking part in this study is voluntary. You may choose not to take part or may leave the study 
at any time. Leaving the study will not result in any penalty or loss of benefits to which you are 
entitled. However, if you decide to stop participating in the study, we encourage you to talk to 
the study doctor and your regular doctor first.
YOUR RESPONSIBILITIES AS A RESEARCH SUBJECT
You will be asked to adhere to all instructions issued by the study doctor and other study staff. 
This also includes arriving on time for examinations. Furthermore, you should answer all asked 
questions truthfully.
Should you not comply with instructions, the study doctor may stop your study participation. 
Your study doctor may also exclude you from this trial if he/she deems it beneficial for your 
health, or if you do not meet the study requirements.
Your participation in this study may be 
ended if the Sponsor stops the study for any reason.   
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WHOM TO CALL IF YOU HAVE QUESTIONS
For questions, concerns or complaints about the study or a research-related injury, contact the 
study doctor at the number on page 1.
This study was reviewed by Aspire Independent Review Board (IRB). An IRB reviews 
research to protect the rights and welfare of study participants. If you have problems, 
concerns, suggestions, complaints, questions or information about the study, and for 
information regarding research subject's rights, please call Aspire's Study Participant Advocate
at 1-877-366-5414 (toll free).
Although Aspire IRB has approved the information provided in this informed consent form and 
has granted approval for the investigator to conduct the study this does not mean Aspire has 
approved your participation in the study.  You must evaluate the information in this informed 
consent form for yourself and decide whether or not you wish to participate.
SIGNATURE AND CONSENT TO BE IN THE STUDY
Your signature below means that you have read the above information about this study and 
have had a chance to ask questions to help you understand what you will be expected to do 
and that you agree to participate in this study.
Your signature also means that you have had 
all your questions answered to your satisfaction and that you have been told that you can 
change your mind later if you want to.  You will be given a signed and dated copy of this 
agreement.  By signing this consent form, you are not giving up any of your legal rights. 
________________________________________________ _________/________
SIGNATURE OF SUBJECT 
 
 
 
 
 
DATE  
 
________________________________________________
PRINTED NAME OF SUBJECT
I confirm that a copy of this consent form has been given to this person to read and that this 
person has been told about the study.  The contents of the consent form describing the study 
has been discussed with this person and I have made every effort to answer all questions to 
his or her satisfaction.  I have watched this person sign the consent form.
_______________________________________________
__________/________
SIGNATURE OF PERSON OBTAINING CONSENT  
 
DATE  
 
_______________________________________________
PRINTED NAME OF PERSON OBTAINING CONSENT
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Appendix 4: IRB Approval
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STUDY APPROVAL NOTIFICATION
iLux™ Safety Study
Sponsor:   
 
 
 
Tear Film Innovations, Inc.
Protocol Number:    
 
2020-02
 
 
 
 
 
March 2, 2016
The new study listed above was reviewed at the March 08, 2016 meeting of Aspire IRB. In addition, 
the iLux User Manual dated August 22, 2015 & iLux Device Description dated July 15, 2015 was 
given full review.
This study was approved at that time with the following conditions:
x
Informed Consent revised for readability and clarity purposes and to ensure all 
applicable required elements of consent are satisfied.
The above-referenced conditions have been met and this study received unconditional approval 
on March 16, 2016. 
Jim Owen, OD was approved to conduct this study at the following locations:
Encinitas Optometry
681 Encinitas Blvd., #302
Encinitas, CA  92924
In addition, Aspire IRB is in receipt of requested changes to the Informed Consent document for the 
above referenced study.  This document has been revised to:
x
Clarification and explanation of the slit lamp procedure
Changes to this document do not negatively impact subject safety or study integrity.  These changes 
have been approved through expedited review by Susan Abramson, MD, Aspire IRB Board Member, 
on March 16, 2016.  
You must use the enclosed approved consent documentation stamped with “Aspire IRB Approved” 
located at the bottom of each page.    
x
Informed Consent Document dated March 16, 2016
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Additional Materials:
x
Print Advertisement - Approved March 8, 2016
x
Corneal Fluorecein Staining Guide - Acknowledged March 8, 2016
x
Medical Ocular History - Approved March 8, 2016
The IRB has determined that your study is More Than Minimal risk. This study involves an 
investigational medical device; the Board agrees with the Sponsor’s submitted Non-Significant
determination for the proposed use in this study. It has been assigned an approval period of Annual
review.  Your approval period ends March 7, 2017; as a reminder, you will receive a Research Status 
Report Form approximately sixty days prior to this date.
The Principal Investigator is responsible for providing the IRB with the necessary materials for re-
approval by the due date provided on the form. This form must be received by the due date to allow 
ample time for adequate review prior to the study’s expiration date. Missed submissions are the 
responsibility of the Principal Investigator regardless of whether or not the IRB notifies you.  
The continuation of research after expiration of IRB approval is a violation of the regulations 
governing research.  
Please be aware that while your study has now received IRB approval, FDA approval to proceed is still 
required (if applicable).  It is your responsibility to ensure that you have a valid FDA approval/clearance, 
before you move forward with study procedures or subject recruitment.  It is your responsibility to notify 
Aspire, if the FDA or any other regulatory agency delays or puts a hold on your research. 
It is required that Aspire IRB be notified of:
o
All amendments or changes to the protocol
o
Changes to the protocol that are implemented without prior IRB approval to eliminate an 
apparent immediate hazard to subjects (must be reported within 24 hours of implementation)
o
Unanticipated problems involving risks to subjects or others (within 10 calendar days of
discovery) this includes protocol deviations that fit the criteria for an unanticipated problem.
o
All material used to recruit study subjects (prior IRB approval is required before use)
o
Any other changes in the research activity
The Principal Investigator may not make any changes in the research, without prior approval of Aspire 
IRB, except when necessary to eliminate immediate risk to study subjects.  In addition, it is the 
responsibility of the Principal Investigator to uphold the following three ethical principles outlined in the 
Belmont Report during the conduct of this study: 
o
Respect for persons: individuals should be treated as autonomous agents, and persons with 
diminished autonomy are entitled to protection.
o
Beneficence: maximize possible benefits and minimize possible harms.
o
Justice: benefits and burdens of research should be distributed equally.
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Aspire IRB is duly constituted and has written procedures in compliance with requirements defined in 
21 CFR Parts 50 and 56, 312, 812, 45 CFR 46 and ICH Guidelines relating to Good Clinical Practice.  
Aspire IRB’s mission is to ensure that research is conducted ethically according to the principles of the 
Belmont Report and in compliance with federal regulations, international regulations, ICH Guidelines for 
Good Clinical Practice, applicable state and local laws, Aspire IRB Standard Operating Procedures, 
and that the rights and welfare of human subjects are protected.   
Sincerely,
Aspire IRB
AFD
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April 27, 2016
Jim Owen, OD
Encinitas Optometry
681 Encinitas Blvd., #302
Encinitas, CA 92924
Re:
Protocol Amendment No. 1 dated April 25, 2016
Sponsor: Tear Film Innovations, Inc. 
 
 
Protocol Number: 2020-02
Dear Dr. Owen, 
Aspire IRB is in receipt of Protocol Amendment No. 1 dated April 25, 2016 for the above 
referenced study.  This amendment was issued to: 
x
Clarify the i-Lux  procedure 
x
Update the statistical methods
x
Update the name of the scores of the discomfort/pain scale from “ specific 
scores” to “descriptive anchors” 
x
Make typographical, formatting and grammatical changes
This amendment required no changes to the previously approved Informed Consent document 
and this document will not be reissued.
This amendment does not negatively impact subject safety or study integrity.  These changes 
have been approved through expedited review by Susan M. Abramson, MD, Aspire IRB Board 
Member, on April 27, 2016. 
A copy of this documentation should be forwarded to the sponsor/CRO for their records and 
maintained in your files for future reference.
If we can be of further assistance, please do not hesitate to contact our office.
Sincerely,
Aspire IRB
AFD
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