Study of the TearCare System in Dry Eye Disease
Phase: NA
Conditions: Dry Eye
Sponsor: Sight Sciences, Inc.

 
 
Study of the TearCare® System in Dry Eye Disease
 
Protocol 06001 Rev C 
 
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Official Title : To evaluate the safety and 
effectiveness of a single TearCare® 
procedure to treat adult patients with dry eye 
disease. (CHEETAH) 
Unique Protocol ID: 06001 
NCT number : NCT03588624 
Document Date: 07.30.2018 
Sight Sciences, Inc. 
 

 
 
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STUDY OF THE TEARCARE® SYSTEM IN DRY EYE DISEASE 
 
PROTOCOL ID #: 
 
06001 
CURRENT REVISION: 
 
C 
REVISION DATE: 
 
July 30, 2018 
SPONSOR: 
Sight Sciences, Inc. 
3000 Sand Hill Road 
Building 3, Suite 105 
Menlo Park, CA  94025 
877-266-1144 
 
 
Agreement of Principal Investigator 
I,  
 
 
 
 
 
  agree to conduct this trial in accordance 
with this clinical protocol and any amendments. 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Center Name  
 
 
 
 
City, State, Country 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation.  It must be held 
confidential and maintained in a secure location. 

 
 
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Do not copy or distribute without written permission. 
 

 
 
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Revision History 
 
Revision 
Date  
ECO 
A 
June 5, 2018 
2457 
B 
July 2, 2018 
2485 
C 
July 30, 2018 
2511 
 

 
 
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TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ...................................................................................................................... 8 
2 
STUDY OBJECTIVE ......................................................................................................................... 12 
3 
BACKGROUND AND JUSTIFICATION FOR THE STUDY .................................................................... 12 
4 
DESCRIPTION OF DEVICE ............................................................................................................... 15 
4.1 
CURRENT INDICATION FOR USE .............................................................................................................. 15 
4.2 
DEVICE DESCRIPTION ........................................................................................................................... 15 
4.3 
INSTRUCTIONS FOR USE ........................................................................................................................ 18 
4.4 
TRAINING .......................................................................................................................................... 18 
5 
PRIOR INVESTIGATIONS ................................................................................................................ 18 
5.1 
PRECLINICAL TESTING ........................................................................................................................... 18 
5.2 
PREVIOUS CLINICAL EXPERIENCE ............................................................................................................ 19 
6 
STUDY ENDPOINTS ....................................................................................................................... 21 
6.1 
EFFECTIVENESS ENDPOINTS ................................................................................................................... 21 
6.2 
SAFETY ENDPOINTS.............................................................................................................................. 22 
7 
STUDY DESIGN .............................................................................................................................. 22 
8 
STUDY SELECTION CRITERIA .......................................................................................................... 22 
8.1 
INCLUSION CRITERIA ............................................................................................................................ 22 
8.2 
EXCLUSION CRITERIA ............................................................................................................................ 23 
9 
STUDY PROCEDURES ..................................................................................................................... 24 
9.1 
STUDY SCHEDULE ................................................................................................................................ 24 
9.2 
NUMBER OF SUBJECTS AND DURATION OF FOLLOW-UP .............................................................................. 25 
9.3 
MATERIAL AND EQUIPMENT .................................................................................................................. 25 
9.4 
INFORMED CONSENT AND POINT OF ENROLLMENT .................................................................................... 26 
9.5 
BASELINE VISIT ................................................................................................................................... 26 
 
Scheduling the Baseline Visit ................................................................................................ 26 
 
Baseline Exams and Questionnaires ..................................................................................... 26 
 
TearCare Procedure .............................................................................................................. 27 
 
Management of Dry Eye Symptoms During Follow-Up ........................................................ 28 
9.6 
FOLLOW-UP VISITS .............................................................................................................................. 29 
9.7 
WITHDRAWAL AND DISCONTINUATION .................................................................................................... 29 
10 
ADVERSE EVENTS (AES) ................................................................................................................. 30 
10.1 
DEFINITIONS OF AE, SAE, SADE, USADE .......................................................................................... 30 
10.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS ............................................................................... 31 
10.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS ........................................... 31 
11 
RISK-BENEFIT ANALYSIS ................................................................................................................ 32 
11.1 
ANTICIPATED CLINICAL BENEFITS ........................................................................................................ 32 
11.2 
ANTICIPATED ADVERSE DEVICE EFFECTS ............................................................................................... 32 
11.3 
RESIDUAL RISKS ASSOCIATED WITH THE TEST DEVICE, AS IDENTIFIED IN THE RISK ANALYSIS REPORT .................. 32 
11.4 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION ................................................... 33 
11.5 
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS ....................................................... 33 

 
 
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11.6 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ............................................................. 33 
12 
STATISTICAL CONSIDERATIONS ..................................................................................................... 34 
12.1 
HYPOTHESIS .................................................................................................................................. 34 
12.2 
SAMPLE SIZE CALCULATION .............................................................................................................. 34 
12.3 
PASS/FAIL CRITERIA ........................................................................................................................ 34 
12.4 
EVALUABILITY ................................................................................................................................ 34 
12.5 
ANALYSIS POPULATIONS .................................................................................................................. 35 
12.6 
SUBJECT ACCOUNTABILITY ................................................................................................................ 35 
12.7 
STATISTICAL DESIGN, METHOD & ANALYTICAL PROCEDURES TO BE USED .................................................. 35 
12.8 
INTERIM ANALYSIS AND EARLY TERMINATION CRITERIA .......................................................................... 35 
12.9 
DEVIATION FROM THE STATISTICAL PLAN ............................................................................................ 35 
13 
MONITORING PROCEDURES ......................................................................................................... 35 
14 
DATA AND QUALITY MANAGEMENT ............................................................................................. 36 
14.1 
DATABASE MANAGEMENT ............................................................................................................... 36 
14.2 
CONFIDENTIALITY ........................................................................................................................... 36 
14.3 
SOURCE DATA AND CASE REPORT FORMS ........................................................................................... 37 
14.4 
RETENTION PERIOD......................................................................................................................... 37 
15 
PROTOCOL MODIFICATIONS AND DEVIATIONS ............................................................................. 37 
16 
DEVICE FAILURES AND MALFUNCTIONS ........................................................................................ 38 
17 
ETHICAL CONSIDERATIONS ........................................................................................................... 38 
17.1 
DECLARATION OF HELSINKI ............................................................................................................... 38 
17.2 
INSTITUTIONAL REVIEW BOARDS (IRB) ............................................................................................... 38 
17.3 
INFORMED CONSENT FORM (ICF) ..................................................................................................... 38 
17.4 
PUBLIC LISTING OF STUDY ................................................................................................................ 39 
18 
STUDY ADMINISTRATION ............................................................................................................. 39 
18.1 
DEVICE ACCOUNTABILITY ................................................................................................................. 39 
18.2 
EARLY TERMINATION OR SUSPENSION OF AN INVESTIGATION .................................................................. 39 
18.3 
INVESTIGATOR RESPONSIBILITIES ....................................................................................................... 40 
 
General Responsibilities of Investigators ......................................................................... 40 
 
Specific Responsibilities of Investigators .......................................................................... 40 
 
Investigator Records ........................................................................................................ 40 
 
Investigator Reports ......................................................................................................... 41 
18.4 
INVESTIGATOR AGREEMENT .............................................................................................................. 42 
19 
BIBLIOGRAPHY .............................................................................................................................. 42 
20 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES ........................................... 44 
20.1 
OSDI ........................................................................................................................................... 44 
20.2 
MEDICATIONS ................................................................................................................................ 44 
20.3 
SLIT LAMP EXAM ............................................................................................................................ 44 
20.4 
TEAR BREAKUP TIME (TBUT) ........................................................................................................... 45 
20.5 
CORNEAL STAINING ........................................................................................................................ 47 
20.6 
CONJUNCTIVAL STAINING ................................................................................................................. 47 
20.7 
MEIBOMIAN GLAND SECRETION SCORING ........................................................................................... 49 
21 
APPENDIX B - DECLARATION OF HELSINKI..................................................................................... 50 

 
 
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1 PROTOCOL SYNOPSIS 
Protocol Title 
Study of the TearCare® System in Dry Eye Disease 
Protocol ID Number 
06001 
Study Device 
TearCare® System 
Primary Objective 
To evaluate the safety and effectiveness of a single TearCare® 
procedure to treat adult patients with dry eye disease. 
Study Design 
Prospective, single-arm, exploratory treatment study 
Primary Effectiveness 
Endpoint 
• Tear Break-Up Time (TBUT) 
Secondary Effectiveness 
Endpoints 
• Ocular Surface Disease Index (OSDI) score 
• Corneal staining scores 
• Conjunctival staining scores 
• Total Meibomian Gland Secretion Score 
Safety Endpoints 
• Device-related adverse events  
• Best spectacle corrected visual acuity (Snellen) 
Inclusion Criteria 
1. At least 22 years of age 
2. Reports dry eye symptoms within the past 3 months 
3. Reports having to use artificial tears or lubricants regularly 
over the past month to relieve dry eye symptoms. 
4. OSDI Score of ≥23  
5. TBUT of ≤7 seconds in both eyes  
6. Meibomian gland obstruction in both eyes based on a total 
Meibomian Gland Secretion Score ≤15 in each eye.  
7. At least 15 glands in each lower eyelid should be expressible, 
with a sterile cotton swab, at the slit lamp. 
8. Best spectacle corrected visual acuity of 20/100 or better in 
both eyes. 
9. Willing and able to comply with the study procedures and 
follow-up 
10. Willing and able to provide informed consent 
11. English-speaking 

 
 
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Exclusion Criteria 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Any active, clinically significant ocular or peri-ocular infection 
or inflammation 
2. Recurrent clinically significant eye inflammation, other than 
dry eye, within 3 months prior to enrollment 
3. History of eyelid, conjunctiva or corneal surgery (including 
refractive surgery) within the past year.  In addition, subjects 
with any history of the following are excluded: chalazion 
surgery, surgery on the tarsal conjunctiva, radial keratotomy 
(RK), complicated blepharoplasty, lid reconstruction, or 
significant complications post-refractive surgery. 
4. Any office-based dry eye treatment (e.g. IPL, thermal 
pulsation [Lipiflow], etc.) within 12 months prior to 
enrollment.  In addition Blephex or debridement within 3 
months prior to enrollment is an exclusion. 
5. Meibomian gland expression within 6 months prior to 
enrollment.  In addition, any history of meibomian gland 
probing is an exclusion. 
6. In the clinical judgement of the investigator, meibomian 
glands have significant capping, atrophy, or are unable to be 
expressed, digitally or with a sterile cotton swab. 
7. Contact lens use within the past 2 weeks  (Subjects must 
refrain from wearing contact lenses for the duration of the 
study.) 
8. Use of TrueTear device within the past 2 weeks  (Subjects 
must refrain from using the TrueTear device for the duration 
of the study.) 
9. History of Ocular Herpes Simplex or Ocular Herpes Zoster 
10. Clinically significant ocular surface abnormalities that may 
affect tear film distribution or treatment (e.g. pterygium, 
anterior membrane dystrophy, etc.) 
11. Clinically significant eyelid abnormalities in either eye (e.g. 
entropion/ectropion, blepharospasm, aponeurotic ptosis, 
lagophthalmos, notching of lid margin, distichiasis, trichiasis) 
12. Clinically significant anterior blepharitis.  In addition, 
collarettes or flakes of more than one quarter of the eyelid 
are excluded. 
13. Clinically significant dermatologic or cutaneous disease of the 
eyelid or periocular area 
14. Ocular trauma within 3 months prior to enrollment 
15. Any active, clinically significant allergic, vernal, or giant 
papillary conjunctivitis 
16. Known history of diminished or abnormal facial, periocular, 

 
 
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Exclusion Criteria 
(continued) 
ocular or corneal sensation 
17. Corneal surface abnormalities such as corneal epithelial 
defects (other than punctate staining), ulcers, corneal 
epithelial dystrophies, keratoconus, and ectatic disease of 
the cornea 
18. Punctal occlusion or punctal plug placement within 30 days 
prior to enrollment 
19. Systemic diseases resulting in dry eye (e.g. autoimmune 
diseases such as Sjogren’s syndrome, rheumatoid arthritis, 
lupus, Graves’ disease, sarcoidosis, etc.) 
20. Allergies to silicone tissue adhesives 
21. Use of Restasis or Xiidra within 60 days prior to enrollment.  
Subject must also be willing to remain off these drugs for the 
duration of the study. 
22. Use of antihistamines (oral or topical) within 10 days prior to 
enrollment.  Subject must also be willing remain off 
antihistamines for the duration of the study. 
23. Subject is currently on a systemic medication(s) (other than 
anti-histamines) that is known to cause ocular dryness (e.g. 
diuretics, anti-hypertensives, anti-depressants, hormone 
therapy) and whose dose of this medication(s) has not been 
stable within 30 days prior to enrollment.  There must be no 
anticipated adjustments to the dose of these medications for 
the duration of the trial. 
24. Subject has taken or is currently taking Accutane 
25. Subject requires chronic use (i.e. for any portion of the study) 
of topical ophthalmic antibiotics, anti-glaucoma medications, 
steroids, non-steroidal anti-inflammatory medications or who 
has been on any of these medications within 30 days prior to 
enrollment 
26. Subject is currently using Retin A or Latisse 
27. Participation in another ophthalmic clinical trial within one 
year prior to enrollment.  Subject must also be willing to 
refrain from another ophthalmic study for the duration of the 
study.   
28. Co-existing condition, either ocular or non-ocular that, in the 
judgement of the investigator could affect the safety or 
effectiveness of treatment or the compliance of the subject 
to the protocol.  Subjects who are pregnant or nursing or 
have active, wet macular degeneration are excluded.   
 
Number of Subjects  
Up to 30 

 
 
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Number of Sites 
2-3 
Study Duration for Each 
Subject 
1 month 
Schedule of Visits 
Baseline, Week 1, 1 Month  
Treatments 
TearCare procedure at Baseline 
 
 
 

 
 
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2 STUDY OBJECTIVE 
The objective of this study is to evaluate the safety and effectiveness of a single 
TearCare® procedure to treat adult patients with dry eye disease. 
3 BACKGROUND AND JUSTIFICATION FOR THE STUDY 
Dry Eye Disease (DED) is a chronic eye condition that can cause an array of symptoms in 
patients, ranging from periodic ocular discomfort to severe corneal inflammation, 
scarring, and vision loss.1,2  Approximately 1/3 of patients visiting their eye doctor suffer 
from dry eye.  The prevalence of dry eye disease increases with age, especially in 
postmenopausal women.  It is estimated that dry eye disease affects more than 7 
million Americans older 40 years of age1, and approximately 1 million to 4 million 
Americans between 65 to 84 years of age.3   
 
Each year in the U.S., billions of dollars are spent on topical lubricants, medications, tear 
duct occlusions, and other treatments to control the chronic condition of dry eye 
disease.  Yu et al reported that the average annual cost of managing a patient with dry 
eye was $783 (range $757 – 809) from the payers’ perspective.4  When adjusted to the 
prevalence of DED nationwide, the overall burden of DED on the US healthcare system 
was estimated to be $3.84 billion.  Moreover, there is a great cost to society in terms of 
decreased productivity due to the symptoms of dry eye.   Yu, et al estimated the societal 
cost to be $11,302 per patient and $55.4 billion to the US society overall.4  Essentially, 
not only do dry eye patients directly suffer, but there is also a burden to healthcare, 
employers, and society. 
 
Historically, dry eye disease has been categorized into one of two forms, aqueous tear 
deficiency and evaporative tear deficiency.  The current understanding is that 
evaporative dry eye is more common than aqueous deficient dry eye.5  However, 
because the symptoms of aqueous-deficient dry eye are difficult to differentiate from 
those of evaporative dry eye, it is often impossible to truly separate patients into 
 
1 The definition and classification of dry eye disease: report of the Definition and Classification 
Subcommittee of the International Dry Eye Work Shop. Ocul Surf. 2007;5:75–92. 
2 Lemp MA, Crews LA, et al. Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based 
Patient Cohort: A Retrospective Study. Cornea. 2012: 31: 472-478. 
3 Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care 2011; 17 
Suppl 16:S432-9. 
4 Yu J, Asche CV, Fairchild CJ.  The economic burden of dry eye disease in the United States:  a decision 
tree analysis.  Cornea 2011;30(4):379-87. 
5 Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tusbota K, 
Stapleton F.  TFOS DEWS II Definition and Classification Report.  The Ocular Surface 2017;15:276-283. 

 
 
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distinct groups.6  In fact, AAO guidelines state that these conditions coexist in the 
majority of the patients with the disease.7   
 
In terms of the mechanism of action for dry eye disease, the International Dry Eye 
Workshop (DEWS)1 explained that tear hyperosmolarity and the symptoms of dry eye 
result from water evaporation caused by low aqueous tear flow and/or excessive 
evaporation.  This reduced, concentrated tear volume, in turn results in further 
inflammation and tear film instability creating a vicious cycle.  The DEWS report 
concluded the following:  “Since both aqueous tear deficiency and increased 
evaporative tear loss occur in most cases of dry eye disease and are linked by common 
pathogenetic mechanisms, expert clinicians are increasingly basing treatment decisions 
on an assessment of severity rather than discrete deficiencies.”8 
 
Normal tears coat the ocular surface and perform many functions, including lubrication 
of the ocular surface, protection from infection, nourishing the ocular surface cells, and 
providing an optically clear surface to properly refract light. Tears consist of three layers: 
 
1. An underlying mucin layer which acts as a wetting agent to spread tears 
uniformly on the ocular surface to prevent beading or irregularity; 
2. An aqueous layer to maintain an optically clear medium and to keep the ocular 
surface moist and healthy; and 
3. A superficial lipid layer to retard evaporation of the aqueous layer. 
When any of these layers is disturbed, tears may lose their protective and optical 
properties leading to a constellation of symptoms, a cascade of inflammatory processes, 
and the vicious cycle of dry eye. 
 
With the most recent etiologies of dry eye disease in mind, multiple standard-of-care, 
therapeutic approaches are employed: 
 
1. Supplementation of the tear film with artificial tears to address evaporation and 
maintain tear volume 
2. Use of warm compress and lid massage to improve lipid production and flow on 
the tear film 
3. Use of immunosuppressives (cyclosporine, corticosteroids, lifitegrast) to reduce 
inflammation  
 
6 Geerling G, Tauber J, Baudouin C, et al. The international workshop on meibomian gland dysfunction: 
report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest 
Ophthal-mol Vis Sci 2011;52:2050-64 
7 American Academy of Ophthalmology’s Dry Eye Syndrome Preferred Practice Pattern 2013.  
8 Lemp M, Foulks, G.  The Definition & Classification of Dry Eye Disease:  Guidelines from the 2007 
International Dry Eye Workshop.  April 2008.  
http://www.tearfilm.org/pdfs/OM%20-%20Definition%20&%20Classification.pdf 

 
 
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4. Placement of punctal plugs to address evaporation and maintain tear volume 
 
Recently, a great deal of evidence suggests that obstruction of the meibomian glands, 
which are the glands on the eyelid that produce the lipid layer of tears, is strongly 
associated with dry eye disease.9,10,11,12    The DEWS II report states that meibomian 
gland disease is considered the leading cause of dry eye in clinic and population-based 
studies.13  As these glands become either inflamed or obstructed, their ability to supply 
the essential lipids to the ocular surface is diminished. This, in turn, leads to rapid 
evaporation of tears and thus to the signs and symptoms of dry eye disease.14  When 
this occurs, it can result in ocular discomfort and, in many cases, ocular surface 
disorders that can affect the quality of vision and/or visual acuity.   
 
Sight Sciences has developed the TearCare™ System to provide a safe and effective 
treatment for the signs and symptoms of dry eye disease.  The System is designed to 
conform to the eyelids to deliver controlled, precise heat to the tarsal plates and 
underlying meibomian glands of the eyelids for 15 minutes in the monitored setting of 
an ophthalmologist or optometrist office. In addition to blinking during TearCare™ 
treatment to naturally express melted meibum, the physician then uses physician gland 
clearing devices to further express the meibomian glands manually immediately (i.e., 
within 3 minutes) following the eyelid heat treatment.   
 
The objective of this study is to evaluate the safety and effectiveness of the TearCare 
System to treat the signs and symptoms of dry eye disease.   
 
9 Korb DR, Blackie CA. Meibomian gland diagnostic expressibility: correlation with dry eye symptoms and 
gland location. Cornea. 2008;27: 1142–1147. 
10 Korb DR, Henriquez AS. Meibomian gland dysfunction and contact lens intolerance. J Am Optom Assoc. 
1980;51:243–251. 
11 Blackie CA, Korb DR, Knop E, et al. Nonobvious obstructive meibomian gland dysfunction. Cornea. 
2010;29:1333–1345. 
12 Maskin SL. Intraductal meibomian gland probing relieves symptoms of obstructive meibomian gland 
dysfunction. Cornea. 2010;29: 1145–1152. 
13 Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tusbota K, 
Stapleton F.  TFOS DEWS II Definition and Classification Report.  The Ocular Surface 2017;15:276-283. 
14 Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004;2:149–165. 

 
 
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4 DESCRIPTION OF DEVICE 
4.1 CURRENT INDICATION FOR USE 
The TearCare System is a Class II exempt device that is listed with the FDA.  It is 
commercially available in the US.  It is currently labeled with the following indication for 
use:   
“The TearCare® System is indicated for the application of localized heat when the 
current medical community recommends the application of a warm compress to 
the eyelids. Such applications would include Meibomian Gland Dysfunction 
(MGD), Dry Eye, or Blepharitis.” 
4.2 DEVICE DESCRIPTION  
The TearCare System is designed to deliver controlled, precise heat to the tarsal plates 
and underlying meibomian glands of the eyelids for 15 minutes, followed immediately 
by manual mechanical meibomian gland expression.  The TearCare procedure takes 
place in the monitored setting of an ophthalmologist or optometrist office. 
 
The Sight Sciences’ TearCare System is comprised of the following components: 
 
• iLidTM Devices 
• SmartHubTM Kit, including SmartHub Nest, and charging adapter 
• ExpressTM Forceps 
 
The 4 iLid devices are custom designed to conform to the tarsal plate of each respective 
eyelid so that patients can blink normally throughout the treatment and naturally 
express melted meibum with every blink.  Immediately following the thermal treatment 
(i.e., within 3 minutes after treatment), the physician uses the forceps to further express 
the meibomian glands manually to maximize the evacuation of melted meibum. 
 
The iLid Devices, shown below in Figure 1, are single-use, flexible, sensor-controlled 
devices that adhere to each of the 4 eyelids.  They contain flexible circuits, sensors and a 
microprocessor which provide accurate and precise thermal energy to the eyelids to 
melt oil in the meibomian glands (meibum).  Medical grade adhesive on the skin-facing 
surface of the iLid devices allow them to be affixed to the external surface of the eyelids 
during the procedure and easily removed at the end of the procedure.  The flexibility of 
the iLid devices permit them to remain attached to the eyelids throughout the 
procedure while patient blinks normally.   

 
 
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The iLid devices are connected to the TearCare SmartHub via a cable.  The TearCare 
SmartHub, shown below in Figure 2, delivers electrical energy to the iLid Devices, which 
is subsequently converted into thermal energy.  Embedded software and a closed loop 
sensor system ensures that the temperature delivered at the eyelids is maintained 
within a precise range (41 to 45°C). A control button on the center of the SmartHub is 
used to turn the system on and off and to initiate or discontinue the TearCare session.  
Two buttons, “+” and “-“, on the left side of the face of the SmartHub allow the user to 
adjust the temperature to a level that is comfortable for the patient.  The current 
warmth setting is indicated by the warmth level indicators between the two adjustment 
buttons.  The SmartHub also has a display on the right side of its face that indicates how 
much time is left in the session.   The TearCare SmartHub is battery operated, with a 
built-in battery, and is recharged by placing it on the charging nest. 
The Express Forceps (shown in Figure 3 below) is a single-use, sterile devices that are 
designed to facilitate manual expression of the meibomian glands after the application 
of heat by the TearCare iLid devices. 
 
Figure 1:  iLid Devices applied to the Eyelids 
 
 

 
 
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Figure 2:  TearCare SmartHub 
  
 
 
Figure 3:  Express Forceps 
 
 
 
To use the System, the flexible iLid devices are applied to the external surface of the 
upper and lower eyelids of the patient (Figure 1).   The iLid devices are then connected 
to the TearCare SmartHub.  When the SmartHub is turned on and the physician initiates 
the procedure, the TearCare System begins delivering heat to the eyelids.  The system 
automatically and gradually increases the temperature over 2-3 minutes until it reaches 
the maximum set point temperature of 45°C.  A complete TearCare session lasts 15 
minutes.    
The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the 
user to manually adjust the temperature up or down to a level that is comfortable for 
the subject.  The set points can be adjusted at any time during the treatment session. 
Subjects can blink naturally during the session. 
Time remaining 
indicator 
On/Off button 
# Sessions 
remaining on the 
battery 
Temperature 
setting indicator 
and adjustment 
buttons (+ and -) 

 
 
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The temperature range for the TearCare System was selected based on research that 
has shown that meibum will melt at temperatures between 32 to 45°C, but obstructed 
glands may require higher temperatures, around 45°C, to effectively melt meibomian 
obstructions.15,16,17  The maximum temperature and 15 minute treatment duration is 
also well below the time-temperature threshold at which heat contacting the skin will 
first show signs of cutaneous damage and edema, and is within the safety limits 
specified for medical electrical equipment.18,19,20 
Immediately following the TearCare session (i.e. within 3 minutes), the clinician uses the 
forceps to manually express the meibomian glands in all four eyelids.     
4.3 INSTRUCTIONS FOR USE 
Instructions for Use are provided with each TearCare System. 
4.4 TRAINING 
Prior to the start of the study, investigators and study staff who have not been 
previously trained in the proper use of the TearCare System will be trained in its use.  All 
study staff will receive training on the protocol and execution of the study according to 
applicable regulations and Good Clinical Practices. 
5 PRIOR INVESTIGATIONS 
5.1 PRECLINICAL TESTING 
The TearCare System has been tested extensively on the bench and in clinical validation 
testing to demonstrate that it meets all specified safety and performance requirements.  
The following testing and analyses was performed: 
 
• Thermal Requirements:  Bench testing was performed to demonstrate that the 
TearCare System meets the operational temperature requirements (range 41-
 
15 Bron AJ, Tiffany JM.  The contribution of meibomian disease to dry eye.  Ocul Surf. 2004;2:149-165. 
16 Bron AJ, Tiffany JM, Gouveia SM, Yokoi N, Voon LW. Functional aspects of the tear film lipid layer. Exp 
Eye Res 2004;78:347–60. 
17 Jones et al.  TFOS DEWS II Management and Therapy Report.  The Ocular Surface 2017;15:575-628. 
18 Moritz AR, Henriques FC. Studies of thermal injury: the relative importance of time and surface 
temperature in the causation of cutaneous burns. Am J Pathol 1947;23:695–720. 
19 Despa F, Orgill DP, Neuwalder J, Lee RC. The relative thermal stability of tissue macromolecules and 
cellular structure in burn injury. Burns 2005;31:568–77. 
20 Medical electrical equipment  Part 1:  General requirements for basic safety and essential performance 
(IEC 60601-1). 

 
 
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45°C).  Clinical validation testing was also performed in 15 human subjects to 
measure the temperature at the inner and outer surfaces of the eyelid during 
operation of the System and at the surface of the cornea immediately following 
the treatment.  The testing confirmed that the system meets temperature-
related performance and safety specifications.  No adverse events were 
observed.    
• Software Functionality:  Testing was performed to demonstrate that the 
software in the TearCare SmartHub and iLid Devices meet all software design 
requirements. 
• Electrical Safety:  Testing was performed to demonstrate that the System meets 
the electrical safety requirements specified in IEC 60601-1. 
• Electromagnetic Compatibility:  Testing was performed to demonstrate that the 
System meets the electromagnetic requirements specified in IEC 60601-1-2. 
• Biocompatibility:  All patient-contacting materials were reviewed to confirm that 
that they are biocompatible for short-term (<24 hours), skin contact. 
• Mechanical Strength:  Testing was performed to demonstrate that the system 
meets mechanical strength requirements. 
• Shipping, Storage, and Shelf-Life Testing:  Testing was performed to demonstrate 
that the TearCare System continues to function properly after being exposed to 
environmental and shipping conditions specified in ASTM D4169.  In addition, 
accelerated aging testing was performed to demonstrate the iLid devices have a 
minimum shelf life of 6 months. 
5.2 PREVIOUS CLINICAL EXPERIENCE 
The TearCare System has been studied in a single center pilot study conducted in 2017.  
The results were published in Clinical Ophthalmology21 and are summarized below. 
 
Objectives 
The objective of this study was to evaluate the clinical utility, safety, and effectiveness 
of the TearCare™ System compared to standardized warm compress therapy. 
 
Subjects 
Twenty-four (24) subjects with symptoms of dry eye in the past 3 months were enrolled.  
The average age was 67.6 ± 13.5 years (range 29.7 – 89.8 years).  All subjects were 
female, white and not Hispanic or Latino.  All subjects had a SPEED score ≥6 at the 
Baseline visit.  All subjects had a Tear Break-up Time (TBUT) of <10 seconds in at least 
one eye at baseline and 72% (17/24) had a Schirmer 1 score (non-anesthetized) of ≤10 
mm in at least one eye at the Baseline visit.   
 
21 Badawi D.  A novel system, TearCare, for the treatment of the signs and symptoms of dry eye disease.  
Clinical Ophthalmology.  2018;12:683-694. 

 
 
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Methods 
This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects 
with DED were randomized to either a single TearCare treatment conducted at the clinic 
or 4 weeks of daily warm compress therapy. The TearCare procedure consisted of 12 
minutes of thermal eyelid treatment immediately followed by manual expression of the 
meibomian glands.  Warm compress therapy consisted of once daily application of the 
compresses to the eyelids for 5 minutes. Subjects were followed to 6 months post-
treatment. The primary effectiveness endpoint was defined as change from baseline to 
4 weeks for Tear Break-up Time (TBUT).  Secondary effectiveness endpoints included 
meibomian gland assessment, corneal and conjunctival staining scores, and assessment 
of dry eye symptoms using validated questionnaires.  Safety was evaluated by collecting 
device-related adverse events, intraocular pressure, and best spectacle-corrected 
Snellen Visual acuity. 
 
Results 
Twenty-four subjects were enrolled and completed 6 months follow-up.  Data are 
summarized in Table 1 below. 
 
At 1 month follow-up, TearCare subjects demonstrated an improvement from baseline 
in mean (± SD) TBUT of 11.7 ± 2.6 seconds compared with an average worsening of -0.3 
± 1.1 seconds for subjects in the warm compress group (p<0.0001). Significantly greater 
improvements in the change from baseline in meibomian gland scores, as well as 
corneal and conjunctival staining scores were observed in the TearCare group. Subjects 
in the TearCare group also showed significantly greater improvement in dry eye 
symptoms as measured by the three questionnaires.  
   
No adverse events were reported in either group.     
 

 
 
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Table 1:  TearCare System – Pilot Study Results (2017) 
 
TearCare 
(n=24 eyes, 12 subjects) 
Warm Compress control 
(n=24 eyes, 12 subjects) 
 
Baseline  
4 weeks 
6 months 
Baseline  
4 weeks 
6 months 
Tear Break-up Time (sec) – Mean (SD) 
3.1 (0.8) 
14.8 (2.6) 
7.9 (1.5) 
3.3 (1.0) 
3.1 (0.8) 
3.0 (1.0) 
Dry Eye Symptom Questionnaires 
 
 
 
 
 
 
Total OSDI Score (0 to 100) 
41.0 (18.4) 
15.7 (12.2) 
30.3 (15.1) 
33.0 (19.9) 
24.6 (15.2) 
30.3 (15.1) 
Total SPEED Score (0 to 28) 
15.7 (5.2) 
7.8 (3.5) 
8.2 (6.0) 
14.4 (3.8) 
12.6 (3.3) 
12.2 (4.0) 
Total SANDE Score  
64.9 (25.9) 
40.2 (18.8) 
45.9 (30.5) 
55.9 (31.5) 
57.5 (25.7) 
62.1 (21.8) 
Meibomian Gland Assessment 
 
 
 
 
 
 
Total Meibomian Gland Score (0 to 45) 
6.3 (3.6) 
41.0 (2.1) 
31.5 (5.5) 
9.0 (4.3) 
8.2 (4.0) 
9.4 (3.5) 
# Glands Secreting Any Liquid (0 to 15) 
0.8 (0.9) 
14.6 (0.8) 
11.5 (2.4) 
1.3 (1.7) 
1.3 (1.6) 
1.7 (1.5) 
# Glands Yield Clear Liquid (0 to 15) 
0.0 (0.0) 
11.4 (1.6) 
5.4 (3.0) 
0.3 (0.7) 
0.0 (0.0) 
0.1 (0.4) 
Corneal Staining Score (0 to 15) 
3.5 (1.8) 
0.2 (0.4) 
3.2 (2.6) 
3.4 (2.9) 
3.2 (2.6) 
3.2 (2.8) 
Conjunctival Staining Score (0 to 15) 
3.7 (2.5) 
0.1 (0.3) 
0.3 (0.7) 
3.0 (3.4) 
4.1 (3.5) 
3.2 (3.1) 
 
 
Conclusions 
The TearCare Group consistently showed a significant improvement between the 
baseline and 4 weeks follow-up for all outcome measures, whereas the Warm Compress 
group did not.  For all outcome measures, the TearCare Group’s mean change between 
baseline and 4 weeks follow-up was better than the Warm Compress group.  These 
results were maintained out to 6 months. 
 
This pilot study provided preliminary evidence of the safety and effectiveness of the 
TearCare device in relieving the signs and symptoms of dry eye.   
6 STUDY ENDPOINTS 
6.1 EFFECTIVENESS ENDPOINTS 
The following endpoints will be assessed: 
 
• Primary effectiveness endpoint    
o Mean Change from baseline in Tear Break-Up Time (TBUT) 
• Secondary effectiveness endpoints   
o Mean Change from baseline in OSDI score22 
o Mean Change from baseline in the total Meibomian Gland Secretion 
Score23  
 
22 Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL.  Reliability and validity of the Ocular 
Surface Disease Index. Arch Ophthalmol 2000;118: 615-621. 
23 Bron AJ, Benjamin L, Snibson GR. Meibomian gland disease. Classification and grading of lid changes. 
Eye 1991;5: 395–411. 

 
 
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o Mean Change from baseline in corneal staining scores 
o Mean Change from baseline in conjunctival staining scores 
6.2 SAFETY ENDPOINTS 
Safety will be assessed by evaluating the following measures over time: 
 
• Device-related adverse events (all adverse events will be recorded) 
• Best spectacle-corrected visual acuity (Snellen) 
7 STUDY DESIGN 
This is a prospective, single-arm, exploratory treatment study.  This is a post-market 
study intended to collect clinical data regarding the safety and effectiveness of the 
TearCare System.  To reduce potential bias in the study, study staff performing the 
endpoint assessments will be independent of the clinician performing the TearCare 
procedure.   
 
In this study, all subjects will receive the TearCare procedure.  The TearCare procedure 
includes an in-office 15 minute treatment session with the TearCare System 
immediately (i.e. within 3 minutes) followed by manual expression of the meibomian 
glands using the Express Forceps.  Subjects will receive one in-office TearCare procedure 
at the baseline visit and will then have follow-up visits at 1 week and 1 month.   
 
This study will be conducted at 2-3 sites in the United States.   
8 STUDY SELECTION CRITERIA 
8.1 INCLUSION CRITERIA 
For inclusion in this study, subjects must meet all of the following criteria: 
 
1. At least 22 years of age 
2. Reports dry eye symptoms within the past 3 months 
3. Reports having to use artificial tears or lubricants regularly over the past month 
to relieve dry eye symptoms. 
4. OSDI Score of ≥23  
5. TBUT of ≤7 seconds in both eyes  
6. Meibomian gland obstruction in both eyes based on a total Meibomian Gland 
Secretion Score ≤15 in each eye. 

 
 
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7. At least 15 glands in each lower eyelid should be expressible, with a sterile 
cotton swab, at the slit lamp. 
8. Best spectacle corrected visual acuity of 20/100 or better in both eyes. 
9. Willing and able to comply with the study procedures and follow-up 
10. Willing and able to provide informed consent 
11. English-speaking 
8.2 EXCLUSION CRITERIA 
A subject who meets any of the criteria listed below (in either eye) will be excluded from 
the study: 
 
1. Any active, clinically significant ocular or peri-ocular infection or inflammation 
2. Recurrent clinically significant eye inflammation, other than dry eye, within 3 
months prior to enrollment 
3. History of eyelid, conjunctiva or corneal surgery (including refractive surgery) 
within the past year.  In addition, subjects with any history of the following are 
excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy 
(RK), complicated blepharoplasty, lid reconstruction, or significant complications 
post-refractive surgery. 
4. Any office-based dry eye treatment (e.g. IPL, thermal pulsation [Lipiflow], etc.) 
within 12 months prior to enrollment.  In addition Blephex or debridement 
within 3 months prior to enrollment is an exclusion. 
5. Meibomian gland expression within 6 months prior to enrollment.  In addition, 
any history of meibomian gland probing is an exclusion. 
6. In the clinical judgement of the investigator, meibomian glands have significant 
capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton 
swab. 
7. Contact lens use within the past 2 weeks (Subjects must refrain from wearing 
contact lenses for the duration of the study.) 
8. Use of TrueTear device within the past 2 weeks (Subjects must refrain from using 
the TrueTear device for the duration of the study.) 
9. History of Ocular Herpes Simplex or Ocular Herpes Zoster 
10. Clinically significant ocular surface abnormalities that may affect tear film 
distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.) 
11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, 
blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, 
distichiasis, trichiasis) 
12. Clinically significant anterior blepharitis.  In addition, collarettes or flakes of more 
than one quarter of the eyelid are excluded. 
13. Clinically significant dermatologic or cutaneous disease of the eyelid or 
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14. Ocular trauma within 3 months prior to enrollment 
15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis 
16. Known history of diminished or abnormal facial, periocular, ocular or corneal 
sensation 
17. Corneal surface abnormalities such as corneal epithelial defects (other than 
punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and 
ectatic disease of the cornea 
18. Punctal occlusion or punctal plug placement within 30 days prior to enrollment 
19. Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as 
Sjogren’s syndrome, rheumatoid arthritis, lupus, Graves’ disease, sarcoidosis, 
etc.) 
20. Allergies to silicone tissue adhesives 
21. Use of Restasis or Xiidra within 60 days prior to enrollment.  Subject must also be 
willing to remain off these drugs for the duration of the study. 
22. Use of antihistamines (oral or topical) within 10 days prior to enrollment.  
Subject must also be willing remain off antihistamines for the duration of the 
study. 
23. Subject is currently on a systemic medication(s) (other than anti-histamines) that 
is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-
depressants, hormone therapy) and whose dose of this medication(s) has not 
been stable within 30 days prior to enrollment.  There must be no anticipated 
adjustments to the dose of these medications for the duration of the trial. 
24. Subject has taken or is currently taking Accutane 
25. Subject requires chronic use (i.e. for any portion of the study) of topical 
ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-
inflammatory medications or who has been on any of these medications within 
30 days prior to enrollment 
26. Subject is currently using Retin A or Latisse 
27. Participation in another ophthalmic clinical trial within one year prior to 
enrollment.  Subject must also be willing to refrain from another ophthalmic 
study for the duration of the study. 
28. Co-existing condition, either ocular or non-ocular that, in the judgement of the 
investigator could affect the safety or effectiveness of treatment or the 
compliance of the subject to the protocol.  Subjects who are pregnant or nursing 
or have active, wet macular degeneration are excluded.  
9 STUDY PROCEDURES 
9.1 STUDY SCHEDULE 
The Study Schedule is shown below in Table 2. 

 
 
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Table 2:  Study Visit Schedule 
Visit 
(Visit Window) 
Baseline 
(Day 0) 
Wk 1 
 (Day 5-9) 
1 Mo 
(Day 21 – 35) 
Informed Consent 
X 
 
 
Demographics, Ocular & Medical History 
X 
 
 
Medication use 
X 
X 
X 
OSDI* 
X 
X 
X 
Best Spectacle corrected visual acuity (Snellen)* 
X 
X 
X 
Slit Lamp Exam* 
X 
X 
X 
Tear Breakup Time* 
X 
X 
X 
Corneal Staining* 
X 
X 
X 
Conjunctival  Staining* 
X 
X 
X 
Meibomian Gland Secretion Scoring* 
X 
X 
X 
TearCare Treatment 
X 
 
 
AE Assessment* 
X 
X 
X 
Lubricant Drops Log 
 
 
X 
* Endpoint assessment should be performed by an independent study staff who does not 
perform the TearCare procedure on study subjects. 
9.2 NUMBER OF SUBJECTS AND DURATION OF FOLLOW-UP  
Up to 30 subjects will be enrolled and treated in the study.  All subjects will be followed 
for 1 month. 
9.3 MATERIAL AND EQUIPMENT 
A listing of general equipment and materials required at the investigational site for the 
study is provided below. 
 
 TearCare System (including a SmartHub, SmartHub Nest, and charging adapter) 
 TearCare iLid Devices and Physician Gland Clearing Devices 
 Snellen Visual Acuity System 
 Wratten filter (yellow) 
 Meibomian Gland Evaluator (TearScience, Inc.) 
 Fluorescein sodium strips or compounded fluorescein (0.5 – 2%) preservative-
free ophthalmic solution  
 Lissamine green strips 
 0-10µL & 20-200 uL micropipettes and sterile tips 
 Microcentrifuge tubes 
 Preservative-free sterile saline 
 Proparacaine 0.5% or tetracaine 0.5% ophthalmic drops 
 Akten® (lidocaine hydrochloride ophthalmic gel) 3.5% or equivalent 

 
 
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 Stopwatch 
 Makeup remover wipes 
 Sterile scissors 
9.4 INFORMED CONSENT AND POINT OF ENROLLMENT 
The IRB-approved informed consent will be presented and explained to each 
prospective subject by the investigator or a trained clinical professional.  Once the 
subject has had ample time to read the consent form, has been informed of all aspects 
of the study, and has had an opportunity to ask questions, the subject will be given a 
choice to voluntarily confirm his or her participation in the study as documented by 
completion of the Informed Consent.  After signing the Informed Consent and the HIPAA 
(Health Insurance Portability and Accountability Act) authorization, the subject can then 
proceed with the baseline visit.  The subject has the right to withdraw from the study at 
any time without consequences, as indicated in the Informed Consent Document. 
 
The subject’s signed and dated informed consent must be obtained before conducting 
any procedure specifically for the study.  Subjects are enrolled upon signing the ICD 
even if they subsequently fail to meet the eligibility criteria.   
 
The principal investigator(s) must retain the original, signed written Informed Consent 
Document.  A copy of the written Informed Consent Document must be given to the 
subject. 
9.5 BASELINE VISIT 
 SCHEDULING THE BASELINE VISIT 
Since dry eye drops and lubricants can affect the endpoint assessments, instruct 
subjects not to use any of these products within 2 hours of the Baseline visit. 
 BASELINE EXAMS AND QUESTIONNAIRES 
After the subject has signed the informed consent form and agreed to participate in the 
study, the exams, tests and questionnaires listed in the Baseline column of Table 2 
should be performed.  Refer to Appendix A for instructions for performing the exams 
and administering the questionnaire. 
 
At this visit, subjects should undergo the following tests and exams, performed in the 
order indicated below, to screen them for the study qualification and to record baseline 
data.  Endpoint assessments (indicated with a *) should be performed by independent 
study staff who does not perform the TearCare procedure on study subjects. 

 
 
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1. OSDI Questionnaire 
2. Demographics, medical and ocular history 
3. Medication use: ocular and systemic 
4. Best-spectacle corrected visual acuity* 
5. Slit Lamp Exam* 
6. Tear Breakup Time* 
7. Corneal staining* 
8. Conjunctival staining* 
9. Meibomian Gland Secretion Scoring* 
If, at any point during the visit the subjects fails to meet a subject selection criterion, 
then the visit can be terminated.  Subjects who fail to meet all the selection criteria will 
be considered a screen failure and will be withdrawn from the study.  Screen failures 
will not count toward the total enrolled and treated number of subjects. 
 
NOTE:  Questionnaire and exam data collected on subjects prior to enrollment as part of 
the routine clinical practice may be used to pre-screen patients for the study.  However, 
once the subject signs the consent form and is enrolled in the study, these 
questionnaires and exams must be repeated following the protocol procedures. 
 
After all required measurements have been obtained and it has been confirmed that the 
subject meets all the Subject Selection Criteria, then the subject will receive the 
TearCare procedure. 
 TEARCARE PROCEDURE 
The TearCare procedure should be performed by a clinician who did not perform the 
Baseline endpoint assessments.  Refer to the TearCare Instructions for Use for detailed 
instructions for operating the TearCare System. 
 
1. Obtain a new set of iLid devices and a TearCare SmartHub with enough battery 
left for at least one procedure.  
2. Wipe the subject’s eyelids and temple with the makeup removal wipe provided 
by the Sponsor.  Allow the skin to dry or pad dry with a tissue.  Use care not to 
allow any of the wipe to get into the eye. 
3. Place a pair of iLid devices on the subject’s eyelids and affix the temple housing 
to the subject’s temple.  Use the clip to secure the cables behind the subject’s 
head. 
4. Connect the iLid devices to the SmartHub. 
5. Inform the subject that the iLid devices will heat up very quickly once the 
TearCare procedure is started. 

 
 
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6. Start TearCare procedure.  Subjects should be encouraged keep their eyes open 
and blink naturally during the TearCare procedure.   
7. If the subject indicates the temperature is too hot, decrease the temperature set  
point to a setting that is comfortable for the subject. 
8. Following the thermal portion of the TearCare treatment, remove the iLid 
devices from the subject and position the subject at the slit lamp to perform 
expression of the meibomian glands.  Begin performing expression within 3 
minutes of completion of the thermal portion of the procedure. 
9. Apply 1 drop of proparacaine or tetracaine into each eye. Apply Akten® 
(lidocaine hydrochloride ophthalmic gel) 3.5% or equivalent into the lower eyelid 
fornices.      
10. Using the Express Forceps, express the meibomian glands in all 4 eyelids using 
the following technique: 
a. Think of each eyelid as having 3 zones:  nasal, central & temporal. 
b. For each zone, start at the fornix and work your way up to the margin. 
c. Position the forceps horizontal, parallel to the margin. 
d. Apply moderate continuous pressure and adjust based on the gland 
output. 
e. Perform a second pass on the same eyelid to further express the glands. 
f. After treating the lower and upper eyelids, repeat expression on all 4 lids 
to ensure complete expression. 
g. Should the subject experience discomfort, it is reasonable to apply 
additional topical anesthetic. 
h. The goal is to express each zone until the meibum coming out is clear.  
Typically, complete expression takes approximately 5 minutes/eye. 
 MANAGEMENT OF DRY EYE SYMPTOMS DURING FOLLOW-UP 
During follow-up, if subjects require relief of their dry eye symptoms, they should only 
use Refresh® Plus drops.  Other types of over-the-counter lubricants should not be used.  
Subjects should record their daily use of lubricants on the Lubricant Drop log. 
 
Subjects should not use any other method of relieving dry eye symptoms, including any 
of the following: 
 
• Warm compress 
• Restasis or Xiidra 
• Other dry eye treatments (e.g. Lipiflow, TrueTear, iLux, punctal plugs, etc.) 
• Lubricants other than Refresh Plus 
 
NOTE:  If a subject had a punctal plug at the baseline visit and it falls out during the 
study, it should be replaced. 

 
 
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Review these instructions with subjects at the end of the Baseline visit and provide them 
with the Lubricant Drop log.  They should complete the log each day and bring it back to 
the clinic at the 1 month follow-up visit. 
9.6 FOLLOW-UP VISITS 
Prior to the Visit:  Reminder Call 
 
Since dry eye drops and lubricants can affect the endpoint assessments, it is important 
to call subjects a few days before their follow-up visits to remind them that on the day 
of the Follow-up visit, they should not to use any of these products before the Follow-up 
visit. 
 
Order of Procedures During the Follow-Up Visit 
 
Follow-up exams should not be performed by the clinician who performed the TearCare 
procedure. 
 
Follow-up procedures will be performed per the Study Schedule provided in Table 2 
(page 25) and the methods included in Appendix A.  Since certain tests/exams can 
impact the ability to perform other tests/exams, the following tests and exams should 
be performed in this order: 
 
1. OSDI 
2. Best spectacle-corrected visual acuity 
3. Slit Lamp Exam 
4. Tear Breakup Time 
5. Corneal staining 
6. Conjunctival staining  
7. Meibomian Gland Secretion Scoring 
8. Assessment of adverse events 
The following activities can be performed in any order: 
• Medication Use 
• Collection of Lubricant Drop Log (1 month visit only) 
9.7 WITHDRAWAL AND DISCONTINUATION 
All subjects have the right to withdraw at any point during the treatment without 
prejudice.  The investigator can discontinue any subject at any time if continued 
participation in the study would result in harm to the subject.  All efforts should be 

 
 
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made by the investigator to retain the subject in the study.  If a subject withdraws 
prematurely from the study, a genuine effort must be made to determine the reason(s) 
the subject discontinued the study.  The reason must be recorded in the subject’s file 
and on the Study Exit Form.   
 
10 ADVERSE EVENTS (AES) 
Adverse Events are defined below.  Adverse events that occur in the eye during the trial, 
whether they are considered to be device related or not, must be documented in the 
subject’s records.  Date of the event, its severity, treatment (if any) and the assessed 
relationship of the event to the study device will be recorded on the Adverse Event 
Form.  Conditions which exist at the time the subject is enrolled do not need to be 
recorded as adverse events unless they increase in severity during the study. 
10.1 DEFINITIONS OF AE, SAE, SADE, USADE 
Adverse Event 
Any untoward medical occurrence in a subject who has been 
treated with the device that does not necessarily have causal 
relationship with the treatment. 
Adverse Device 
Effect 
Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease that is possibly related 
to the study device. 
Serious Adverse 
Event (SAE) 
Any untoward medical occurrence that: 
• Results in death 
• Is life-threatening 
• Requires in-patient hospitalization or prolongs existing 
hospitalization 
• Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent 
damage to a body structure 
• Sight threatening 
Unanticipated 
Adverse Device 
Effect 
Any serious adverse effect on health or safety, 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 
clinical investigational plan; or any other serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects (21 CFR 812.3(s)). Any sight-threatening 

 
 
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event, whether listed in the protocol or not, is considered to be 
reportable as a UADE 
 
10.2 LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS 
Anticipated potential adverse events include those that might reasonably be expected to 
occur in this study because they are associated with dry eye disease, the risk analysis for 
TearCare System (albeit remote likelihood), study testing methods or potential risks 
associated with warm compresses and lid massage.  
• Burn, erythema, or swelling of the eyelids 
• Conjunctival injection (Moderate or severe) 
• Conjunctival abrasion 
• Corneal abrasion  
• Corneal deformation 
• Allergic or inflammatory reaction to medical adhesive on the iLid device 
• Formation of a chalazion or stye 
• Loss in BSCVA of 2 lines or greater from baseline BSCVA 
• Increased discomfort or pain of ocular surface (grittiness, foreign body sensation, 
etc.) 
• Discomfort or pain of eyelids or orbit:  Transient discomfort or pain during the 
TearCare procedure is not considered an adverse event.  Persistent pain or 
discomfort may represent an adverse event, if judged so by the investigator. 
10.3 REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE 
EFFECTS 
Identification, collection and reporting of adverse event information is the responsibility 
of the principal investigator.  The investigator records the date of the event, its severity, 
treatment (if any) and the assessed relationship of the event to the study device on the 
Adverse Event Case Report Form (AE CRF).   
Any ocular-related serious adverse event (SAE) should be reported to the study sponsor 
within one working day of learning of the event.  Non-ocular-related SAEs should be 

 
 
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reported to the study sponsor within two working days of learning of the event.  Email 
the AE CRF to anne@sightsciences.com. 
Any unanticipated adverse device effects (UADE) must be reported to the following 
two entities: 
1. The study sponsor – Within one working day of the investigator first learning of 
the event, e-mail the AE CRF to anne@sightsciences.com; and  
2. The reviewing IRB – As soon as possible, but no later than 10 working days after 
the investigator first learns of the event, report per the IRB’s instructions.  
The sponsor will conduct an evaluation of unanticipated adverse device effects.  If the 
sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to subjects, parts of the investigation presenting risks will be 
terminated.  Termination will occur no later than 5 working days after the sponsor 
makes such a determination and no later than 15 working days after the sponsor first 
received notice of the effect. 
11 RISK-BENEFIT ANALYSIS 
11.1 ANTICIPATED CLINICAL BENEFITS 
The TearCare™ procedure will be performed with the aim of reducing the signs and 
symptoms of dry eye.   The goal of the procedure is to provide a safe, reproducible, and 
effective treatment for dry eye disease, a disease for which there is an unmet need for 
effective therapies. 
11.2 ANTICIPATED ADVERSE DEVICE EFFECTS 
Anticipated adverse effects associated with the TearCare System have been described 
above in Section 10.2. 
11.3 RESIDUAL RISKS ASSOCIATED WITH THE TEST DEVICE, AS IDENTIFIED IN 
THE RISK ANALYSIS REPORT 
Sight Sciences believes that there are no Intolerable residual risks from this non-
invasive, controlled heat treatment device that can be easily and quickly removed by the 
subject or by the supervising ophthalmologist, in the event of a complication during a 
TearCare treatment session. 

 
 
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11.4 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL 
INVESTIGATION 
All anticipated study risks are listed in Section 10.2. 
11.5 POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS 
It is anticipated that there will be no interactions with concomitant medical treatments.   
11.6 STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS 
The major risks to the subjects and the steps taken to control or mitigate them are 
described below: 
 
1. Overheating of the eyelids: All TearCare treatments will be done in the 
investigator’s office under direct supervision of the investigator. The device 
delivers heat to the eyelids at a temperature ranging from 41-45°C.  This 
temperature range was selected because it is both safe for eyelid heating and 
effective for melting obstructions in the meibomian glands.24,25,26,27  The user 
can adjust the temperature up or down to a level that is comfortable, and may 
also shut off the System at any time if it is too uncomfortable or painful.  In 
addition, the TearCare System continuously monitors and regulates the 
temperature at the tissue-contacting surface of the iLid devices and has been 
designed to not exceed the maximum allowable temperature.    
 
2. Corneal abrasion: If the iLid devices are not positioned properly or come loose 
during the treatment, there is the potential for a corneal abrasion. To mitigate 
this, the supervising physician will apply the strips to the subject and will monitor 
their position during the treatment to ensure they remain in place and secure. 
 
In addition, there is the possibility of corneal abrasion or abrasion of the eyelid 
surface during expression of the meibomian glands.  To reduce the chance of 
abrasion, the forceps have been designed with smooth surfaces (i.e. no rough 
edges) and only trained users will perform expression. 
 
24 Lane SS, DuBiner H, Epstein RJ, et al.  A New System, the LipiFlow, for the Treatment of Meibomian 
Gland Dysfunction. Cornea. 2012: 31 : 396-404 
25 Blackie CA, Solomon JD, Greiner JV, Holmes M, Korb DR.  Inner Eyelid Surface Temperature as a 
Function of Warm Compress Methodology.  Optom Vis Sci 2008;85:675-683. 
26 Moritz AR, Henriques FC. Studies of thermal injury: the relative importance of time and surface 
temperature in the causation of cutaneous burns. Am J Pathol 1947;23:695–720. 
27 Medical electrical equipment  Part 1:  General requirements for basic safety and essential performance 
(IEC 60601-1). 

 
 
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3. Worsening of dry eye symptoms:  It is possible that subjects will experience a 
worsening of dry eye symptoms during the study.  Subjects will undergo a 
complete eye exam at each visit and if any untoward or worsening signs of 
ocular surface disease are observed, they will be treated appropriately. 
 
In addition to the above, the following mitigation steps have also been taken to reduce 
the risks in this study: 
 
• The device has been tested to demonstrate that it meets performance and 
safety specifications, as described in Section 5.1. 
• Instructions for Use are provided with each device. 
• The clinician using the device will be trained in how to safely and correctly apply 
and remove the iLid devices, and operate the TearCare System. 
12 STATISTICAL CONSIDERATIONS 
12.1 HYPOTHESIS 
This exploratory study is not a hypothesis-driven study. 
12.2 SAMPLE SIZE CALCULATION 
Given that this is not a hypothesis-driven study, no sample size was calculated for the 
study.  A sample size of up to 30 subjects was chosen for the study as a reasonable 
number of subjects for this exploratory study to evaluate of the safety and effectiveness 
of the TearCare System. 
12.3 PASS/FAIL CRITERIA 
No pass/fail criteria are defined for the study. 
12.4 EVALUABILITY 
All subjects on whom the TearCare device is attempted will be considered evaluable for 
the safety analysis. All eyes that have at least one follow-up visit and have no major 
protocol deviations will be evaluable for the per protocol analysis.  

 
 
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12.5 ANALYSIS POPULATIONS 
The per-protocol analysis population includes all subjects who have at least one post-
treatment visit and have no major protocol deviations, including specifically no use of 
dry-eye medications (Xiidra, Restasis). The primary and secondary endpoint analyses will 
be carried out on the per-protocol population.  The primary analysis population will be 
per-protocol.   
12.6 SUBJECT ACCOUNTABILITY 
A complete accounting of subjects by visit will be provided, including reasons for 
dropout, if known. 
12.7 STATISTICAL DESIGN, METHOD & ANALYTICAL PROCEDURES TO BE 
USED 
Only basic descriptive statistics will be used to analyze data from the study. 
12.8 INTERIM ANALYSIS AND EARLY TERMINATION CRITERIA 
No interim analysis or early termination criteria are planned for this study. 
12.9 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 
 
13 MONITORING PROCEDURES 
Sight Sciences or contract research organization (CRO) personnel will monitor the study 
in a manner consistent with FDA regulations, good clinical practices and the clinical 
research standards adopted by Sight Sciences.  Study monitoring will involve the 
following elements: 
 
• Site Qualification:  For sites that have not already been qualified for another 
Sight Sciences study, Sight Sciences or CRO personnel will meet with 
investigators and clinical study staff prior to the initiation of the study in order 
to review the adequacy of the subject population, facilities, and equipment 
with respect to the needs of the study, and to familiarize the investigator with 
the study protocol.   

 
 
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• Site Initiation:  Sight Sciences or CRO personnel will meet with the 
investigator(s) and clinical study staff when the site is ready to begin enrolling 
subjects in order to train them in how to properly select subjects, perform  the 
study procedure, and record study data.  This visit will include, but not be 
limited to a review of the following: 
o Detailed review of the protocol 
o Informed consent procedures 
o Instruction in how to use the TearCare System 
o Records and reports 
• Interim Monitoring:  Due to the small sample size and one month study 
duration, interim monitoring may not be required.  Sight Sciences or CRO 
personnel may visit the clinical site during the study to review charts and to 
perform source document verification, to ensure proper adherence to the 
study protocol, and to review regulatory documents. 
• Study Closure:  At the conclusion of the trial there will be a study closure visit 
during which several actions, including but not limited to the following, will be 
performed: 
o A final inspection of the study binder 
o Accountability and return of all devices and study materials to the 
sponsor 
o Discussion of record retention requirements with the investigator 
o Close-out notification to the IRB   
14 DATA AND QUALITY MANAGEMENT 
All study-related data will be recorded on Case Report Forms.  When subjects are 
enrolled in the study, they will receive a unique study identifier, which will be used to 
identify them on all Case Report Forms.   The Enrollment log containing the subject 
identifying information and the subject study id will be maintained under the 
investigator’s control at all times.  No subject-identifying information will leave the site. 
 
14.1 DATABASE MANAGEMENT 
Data Management will be performed by Sight Sciences who will create a database or 
spreadsheet in which the study data will be entered.   
14.2 CONFIDENTIALITY 
All medical records associated with the clinical investigation will be made available for 
review by Sight Sciences personnel, its contract research organization (CRO) and 

 
 
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governmental/regulatory agencies involved.  The results of the study may be published 
in the future for scientific and marketing purposes, but the identity (name) of each 
subject will not be revealed.  All records will be stored in a secure area at the 
investigator’s facility, the CRO, the data management firm and at Sight Sciences, Inc. 
14.3 SOURCE DATA AND CASE REPORT FORMS 
Data will be collected directly on the study worksheets provided by the sponsor and 
these study worksheets will serve as the source data.   
 
Source data and study worksheets are to be maintained at the site in the subject 
records or in the medical records.  All entries must be made in black or blue ink and 
changes must be made by strike-through only with date and initials or signature.  All 
source documents must be completed and signed by the authorized study personnel 
(e.g., study coordinator).    No “white-out” is to be used on the source documents. 
14.4 RETENTION PERIOD 
Clinical sites are to retain any and all clinical trial material (documentation, photographs, 
etc.) for a period of two years from the date the marketing application is approved or 
two years after the investigation has been discontinued, or as directed by their 
institutional document retention requirements, whichever is the longest.  After that 
time, the items must be returned to Sight Sciences for archiving.  Unused medical 
devices are to be returned to the sponsor at the conclusion of the enrollment period. 
15 PROTOCOL MODIFICATIONS AND DEVIATIONS 
Protocol modifications may occur during the study.   Each will be approved by the 
sponsor before implementation. Each will undergo Institutional Review Board (IRB) 
review and approval, as necessary. 
 
Any deviations from this protocol intended to protect the life or physical well-being of a 
subject in an emergency are to be reported to Sight Sciences, Inc. as well as the IRB as 
soon as possible, and no later than 5 working days after the emergency occurred. 
 
All protocol deviations will be documented using the Protocol Deviation form. 

 
 
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16 DEVICE FAILURES AND MALFUNCTIONS 
All device failures or malfunctions should be recorded on the Device Deficiency Form 
and reported to Sight Sciences Customer Service (877-266-1144). 
 
If the TearCare procedure cannot be completed due to a product failure or malfunction, 
the procedure may be rescheduled for a different day.  Every effort should be made to 
reschedule the procedure within the next 7 calendar days of the Baseline visit. 
17 ETHICAL CONSIDERATIONS 
17.1 DECLARATION OF HELSINKI 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
B).   
17.2 INSTITUTIONAL REVIEW BOARDS (IRB) 
The study shall not begin at a site until approval has been obtained from the reviewing 
IRB.  It is the Investigators’ responsibility to obtain and maintain written approval of the 
study protocol and Informed Consent documents from the appropriate IRB.  It is also the 
Investigators’ responsibility to notify that body about any amendments to these 
documents and to follow the IRBs rules regarding the reporting of Adverse Events and 
Protocol Deviations related to the device and/or this study.  Copies of all written 
approvals (identifying the study, the submitted and approved documents and the date 
reviewed) and the approved versions of the documents must be provided to Sight 
Sciences or its CRO.  
 
The Investigators must file all correspondence with the IRB and forward copies of such 
correspondence to Sight Sciences. 
17.3 INFORMED CONSENT FORM (ICF) 
An Informed Consent template that covers all protocol procedures and follows GCP 
Guidelines will be prepared by Sight Sciences and made available to each Investigator.  
The Investigator may adapt these templates to the requirements of the local IRB and of 
the institution where the study is conducted, but any revisions made to the ICF must be 
submitted to the sponsor for review prior to submission to the IRB.  A copy of each IRB-
approved ICF version is to be made available to Sight Sciences and its CRO.  The 
approved, IRB-stamped ICF is to be kept in its full length in the study Regulatory Binder.  

 
 
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Original, signed ICFs are to be maintained in the subject’s study records and must be 
made available for monitoring review.  
17.4 PUBLIC LISTING OF STUDY 
The study will be listed on the NIH website www.clinicaltrials.gov.  
18 STUDY ADMINISTRATION 
18.1 DEVICE ACCOUNTABILITY 
With each shipment of study devices, Sight Sciences will include a Packing List that will 
give the amount shipped and the lot numbers. This packing list must be reconciled by 
the investigational site with the contents of the shipment and then recorded on the 
Device Accountability Logs (these logs are contained within the regulatory binder at the 
site).  All study products at the site must be stored in a secured/locked area.  When 
study devices are used, returned or disposed of, their disposition (including the 
disposition and date of disposition) must be recorded on the Device Accountability log. 
 
Device reconciliation activities will also be conducted periodically in conjunction with 
site monitoring visits. The investigator must maintain accurate records of the receipt 
and disposition of all devices shipped by Sight Sciences.   
18.2 EARLY TERMINATION OR SUSPENSION OF AN INVESTIGATION 
Sight Sciences may terminate the study, in which case the investigators and associated 
IRBs will be notified in writing.  Possible reasons for study termination include but are 
not limited to: 
 
• The discovery of an unexpected, significant, or unacceptable risk to the study 
subjects implanted with the device 
• Inability to enroll the study in a reasonable amount of time 
• Withdrawal of FDA listing of the TearCare product. 
 
Sight Sciences reserves the right to stop the study at a center any time after the 
initiation visit if there have been no subject enrollments.     
 
Likewise, a principal investigator may terminate the study at his/her institution.  This 
decision must be followed by written notification to Sight Sciences within five working 
days, stating the reasons for termination. 
 

 
 
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If the study is terminated, every effort should be made to obtain final follow-up from all 
subjects.   
 
In the event that there are significant human use issues with the device, the investigator 
will be consulted to make a determination of whether the study should be terminated 
or not. 
18.3 INVESTIGATOR RESPONSIBILITIES 
 GENERAL RESPONSIBILITIES OF INVESTIGATORS 
An Investigator is responsible for ensuring that an investigation is conducted according 
to the signed agreement, the investigational plan and applicable FDA regulations, for 
protecting the rights, safety, and welfare of subjects under the Investigator’s care, and 
for the control of devices under investigation. An Investigator also is responsible for 
ensuring that informed consent is obtained in accordance with 21 CFR part 50. 
 SPECIFIC RESPONSIBILITIES OF INVESTIGATORS 
1. 
Awaiting approval - An Investigator may determine whether potential subjects 
would be interested in participating in an investigation, but shall not request the 
written informed consent of any subject to participate, and shall not allow any 
subject to participate before obtaining IRB approval. 
2. 
Subject Qualification -The Investigator is responsible for ensuring that all subjects 
entering the study conform to the patient selection criteria. 
3. 
Compliance - An Investigator shall conduct an investigation in accordance with the 
signed agreement with the Sponsor, the investigational plan, all applicable FDA 
regulations, and any conditions of approval imposed by an IRB. 
 INVESTIGATOR RECORDS 
A participating Investigator shall maintain the following accurate, complete, and current 
records relating to the Investigator’s participation in an investigation for the period 
specified in Section 14.4:  
1. 
All correspondence with another Investigator, an IRB, the Sponsor, a monitor, or 
FDA, including required reports. 
2. 
Records of each subject’s case history and exposure to the device. Case histories 
include the study CRF’s/worksheets and supporting data including, for example, 
signed and dated consent forms and medical records.  Such records shall include: 
a) 
Documents evidencing informed consent. 

 
 
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b) All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition 
of each subject upon entering, and during the course of, the investigation, 
including information about relevant previous medical history and the results 
of all diagnostic tests. 
3. 
The protocol, with documents showing the dates and reasons for each deviation 
from the protocol. 
4. 
Any other records that FDA requires to be maintained by regulation or by specific 
requirement for a category of investigations or a particular investigation. 
 INVESTIGATOR REPORTS 
An Investigator shall prepare and submit the following complete, accurate, and timely 
reports: 
1. 
Unanticipated Adverse Device Effects - An Investigator shall submit to the Sponsor 
and to the reviewing IRB a report of any unanticipated adverse device effect 
occurring during an investigation as soon as possible, but in no event later than 10 
working days after the Investigator first learns of the effect. 
2. 
Withdrawal of IRB Approval - An Investigator shall report to the Sponsor, within 5 
working days, a withdrawal of approval by the reviewing IRB of the Investigator’s 
part of an investigation. 
3. 
Progress - An Investigator shall submit progress reports on the investigation to the 
Sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event 
less often than yearly. 
4. 
Deviations from the Investigational Plan - An Investigator shall document and 
report to the Sponsor any deviation from the investigational plan.  
5. 
Informed Consent - If an Investigator enrolls a subject without obtaining informed 
consent, the Investigator shall report such use to the Sponsor and the reviewing 
IRB within 5 working days after the use occurs. 
6. 
Final Report - An Investigator shall, within 3 months after termination or 
completion of the investigation or the Investigator’s part of the investigation, 
submit a final report to the Sponsor and the reviewing IRB. 
7. 
Other - An Investigator shall, upon request by a reviewing IRB or FDA, provide 
accurate, complete, and current information about any aspect of the investigation. 
 

 
 
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18.4 INVESTIGATOR AGREEMENT 
The principal investigators in each center shall agree to the clinical protocol and any 
amendments and indicate their approval and agreement by signing and dating the cover 
page of the study protocol and the Investigator Responsibility Agreement. 
19 BIBLIOGRAPHY 
1. American Academy of Ophthalmology’s Dry Eye Syndrome Preferred Practice 
Pattern 2013.  
2. Badawi D.  A novel system, TearCare, for the treatment of the signs and 
symptoms of dry eye disease.  Clinical Ophthalmology.  2018;12:683-694. 
3. Blackie CA, Solomon JD, Greiner JV, Holmes M, Korb DR.  Inner Eyelid Surface 
Temperature as a Function of Warm Compress Methodology.  Optom Vis Sci 
2008;85:675-683. 
4. Blackie CA, Korb DR, Knop E, et al. Nonobvious obstructive meibomian gland 
dysfunction. Cornea. 2010;29:1333–1345. 
5. Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 
2004;2:149–165. 
6. Bron AJ, Tiffany JM, Gouveia SM, Yokoi N, Voon LW. Functional aspects of the 
tear film lipid layer. Exp Eye Res 2004;78:347–60. 
7. Bron AJ, Benjamin L, Snibson GR. Meibomian gland disease. Classification and 
grading of lid changes. Eye 1991;5: 395–411. 
8. Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols 
JJ, Tusbota K, Stapleton F.  TFOS DEWS II Definition and Classification Report.  
The Ocular Surface 2017;15:276-283. 
9. Despa F, Orgill DP, Neuwalder J, Lee RC. The relative thermal stability of tissue 
macromolecules and cellular structure in burn injury. Burns 2005;31:568–77. 
10. Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J 
Manag Care 2011; 17 Suppl 16:S432-9. 
11. Geerling G, Tauber J, Baudouin C, et al. The international workshop on 
meibomian gland dysfunction: report of the subcommittee on management and 
treatment of meibomian gland dysfunction. Invest Ophthal-mol Vis Sci 
2011;52:2050-64 
12. Gyau DA, Begley CF, Nelson JD.  A simple cost effective method for preparing FL 
and LG solutions. Ocular Surface.  2018;16:139-145. 
13. Jones et al.  TFOS DEWS II Management and Therapy Report.  The Ocular Surface 
2017;15:575-628. 
14. Korb DR, Henriquez AS. Meibomian gland dysfunction and contact lens 
intolerance. J Am Optom Assoc. 1980;51:243–251. 

 
 
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15. Korb DR, Blackie CA. Meibomian gland diagnostic expressibility: correlation with 
dry eye symptoms and gland location. Cornea. 2008;27: 1142–1147. 
16. Lane SS, DuBiner H, Epstein RJ, et al.  A New System, the LipiFlow, for the 
Treatment of Meibomian Gland Dysfunction. Cornea. 2012: 31 : 396-404 
17. Lemp M, Foulks, G.  The Definition & Classification of Dry Eye Disease:  
Guidelines from the 2007 International Dry Eye Workshop.  April 2008.  
http://www.tearfilm.org/pdfs/OM%20-%20Definition%20&%20Classification.pdf 
18. Lemp MA, Crews LA, et al. Distribution of Aqueous-Deficient and Evaporative Dry 
Eye in a Clinic-Based Patient Cohort: A Retrospective Study. Cornea. 2012: 31: 
472-478. 
19. Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical 
Trials in Dry Eyes. CLAO J  1995;21: 221–232. 
20. Maskin SL. Intraductal meibomian gland probing relieves symptoms of 
obstructive meibomian gland dysfunction. Cornea. 2010;29: 1145–1152. 
21. Medical electrical equipment  Part 1:  General requirements for basic safety and 
essential performance (IEC 60601-1). 
22. Moritz AR, Henriques FC. Studies of thermal injury: the relative importance of 
time and surface temperature in the causation of cutaneous burns. Am J Pathol 
1947;23:695–720. 
23. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL.  Reliability and 
validity of the Ocular Surface Disease Index. Arch Ophthalmol 2000;118: 615-
621. 
24. Yu J, Asche CV, Fairchild CJ.  The economic burden of dry eye disease in the 
United States:  a decision tree analysis.  Cornea 2011;30(4):379-87. 
 
 

 
 
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20 APPENDIX A – METHODS FOR EXAMS, TESTS AND 
QUESTIONNAIRES 
20.1 OSDI 
The subject should complete the OSDI at the beginning of each visit before conducting 
other clinical testing.  Provide a paper copy of the questionnaires and a blue or black ink 
pen to the subject.  Review the instructions for the questionnaire with the subject and 
answer any questions they have about how to complete them.  Then allow the subject 
to complete the questionnaires on their own (i.e. self-administered).  The study staff 
should strictly restrain from interpreting the questions, using suggestive comments and 
writing on the questionnaires. 
 
Study staff should review the completed questionnaire before the subject leaves the 
office to check for missing or multiple answers on a given question.  If these are found, 
please point this out to the subject and allow them to revise their response(s) to the 
specific question(s).  Please confirm initials and date of the subject on the last page of 
the questionnaire.  Do not allow the subject to take the questionnaires home. 
 
The OSDI has 12 questions.  Based on the answers provided by the subject, study staff 
calculate the overall OSDI Total score (from 0-100) and scores for the three subscales 
according to the OSDI instructions.  Based on the recommended cutoffs for OSDI Total 
score, the severity of the subject’s dry eye symptoms will be categorized as follows: 
 
o Normal – 0-12 
o Mild – 13-22 
o Moderate – 23-32 
o Severe – 33 or higher  
20.2 MEDICATIONS 
When recording medications that the subject is taking, be sure to ask the subject to list 
any over-the-counter medications and supplements they are taking that could affect dry 
eye disease including, for example, cold medicines, Benadryl, fish oil supplements and 
Omega 3 products, retinol products, Latisse, etc. 
20.3 SLIT LAMP EXAM 
A standard slit-lamp examination shall be performed including inspection of the cornea 
at a magnification of 10X and 16X for the presence or active inflammation or structural 

 
 
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change, the iris and anterior chamber for inflammation, and the eyelids for crusts, 
collarettes, or scales. 
 
20.4 TEAR BREAKUP TIME (TBUT) 
TBUT is an indicator of tear film instability.   
 
Methods for Preparing and Administering Fluorescein into the eye 
 
Any of the following methods may be used to administer fluorescein into the subject’s 
eye.  Whenever possible, the same method should be used for follow-up visits that was 
used for the baseline visit for a particular subject.  In addition, whenever possible, the 
same method should consistently be used at a site on all subjects.   
 
1. DET Strips:   
 
The Dry Eye Test (DET) method should be followed using DET test strips (Amcon 
Laboratories).  While holding a fluorescein impregnated DET strip suspended in air, use a 
micropipette to apply 10uL of sterile saline onto the dyed end of the strip. Do not allow 
the saline to drip off and do not shake the strip. Instill the dyed tip of strip into the lower 
conjunctival fornix. 
 
2.  Compounded Fluorescein Solution 
 
Obtain 0.5%, 1.0% or 2.0% preservative-free fluorescein ophthalmic solution from a 
compounding pharmacy.  Using a micropipette, instill 5uL of the solution into the lower 
conjunctival fornix. 
 
3. Prepare Fluorescein Solution Per the Gyau Method29 
 
a) Put on a pair of sterile gloves. 
b) Cut three (3) 1.0 mg Fluorescein Sodium Ophthalmic strips at the end of the 
colored portion of the strip using sterile scissors and tear each portion into 3 
pieces.  You should have 9 pieces. 
 

 
 
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c) Place the 9 pieces into a disposable microcentrifuge tube.  Make sure the pieces 
of the strips are lying at the bottom part of the tube.  Pipette 200µL of sterile 
saline into the tube containing the cut strips.  Gently shake the tube to make 
sure the fluid is covering all the pieces of the cut strips and cover with the lid. 
 
 
 
d) Wait 3-15 minutes before using the Fluorescein solution.   
e) Using a micropipette, instill 5uL of the solution into the lower conjunctival fornix. 
f) After use, discard the remaining solution and microcentrifuge tube. 
 
 
Measuring Tear Breakup Time 
 
Under the cobalt blue illumination of the slit lamp, tear break-up time should be 
assessed.  Tear Break-up Time is defined as the number of seconds between a blink and 
the appearance of a first dry spot or negative staining in the tear film.   
 
Ask the subject to blink several times before taking the TBUT measurements.  TBUT 
measurements should be done quickly thereafter, since in the presence of epithelial 
defects, the fluorescein will diffuse into the tissue and the borders of staining become 
indistinct, as does the intensity of staining of both tear film and cornea.  Record the 
break-up time using a stopwatch.  Repeat the test 3 times and take the average of the 3 
measurements. 
  

 
 
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20.5 CORNEAL STAINING 
Corneal staining should be assessed immediately following TBUT measurements (i.e. 
within 1-4 minutes after instillation of fluorescein dye) to assure the dye does not 
diffuse into stroma, blurring the discrete margin of any staining defects.  A yellow 
Wratten filter should be used to improve any visualization of corneal staining.  Grade 
the corneal staining using the NEI/Industry Grading System provided in Figure 4 below.28 
 
 
Figure 4:  NEI/Industry Grading System for Corneal and Conjunctival Staining 
 
 
 
20.6 CONJUNCTIVAL STAINING 
Preparation of Lissamine Green Solution29:   
 
28 Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. 
CLAO J  1995;21: 221–232. 
29 Gyau DA, Begley CF, Nelson JD.  A simple cost effective method for preparing FL and LG solutions. 
Ocular Surface.  2018;16:139-145. 

 
 
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g) Put on a pair of sterile gloves. 
h) Cut three (3) Lissamine Green strips at the end of the colored portion of the strip 
using sterile scissors and tear each portion into 3 pieces.  You should have 9 
pieces. 
 
 
 
i) Place the 9 pieces into a disposable microcentrifuge tube.  Make sure the pieces 
of the strips are lying at the bottom part of the tube.  Pipette 200µL of sterile 
saline into the tube containing the cut strips.  Gently shake the tube to make 
sure the fluid is covering all the pieces of the cut strips and cover with the lid. 
 
 
 
j) Wait 5-15 minutes before using the Lissamine Green solution.  After use, discard 
the remaining solution and microcentrifuge tube. 
 
Conjunctival staining:  Instill 10µL of Lissamine Green solution into the lower 
conjunctival fornix. The conjunctival staining grading should be performed 1 minute 
after instillation of stain and within 4 minutes of staining.  Perform a slit lamp exam to 
score the conjunctival staining per the NEI grading system shown above in Figure 4. 
Start with a low illumination and increase the level until the lissamine green staining is 
most visible. The use of an optional red barrier filter between the slit lamp eyepieces 
and the ocular surface highlights the staining pattern. 
 

 
 
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20.7 MEIBOMIAN GLAND SECRETION SCORING 
The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions 
produced by the meibomian glands in the lower eyelids.  The Meibomian Gland 
Secretion Scoring should be performed using the Meibomian Gland Evaluator 
(TearScience, Inc.).  Ensure that the instrument has been cleaned using alcohol prior to 
each use.   
 
Grade the quality of secretions in the lateral, central and temporal thirds of the lower 
eyelids.  Grade the 5 central glands in each region, for a total of 15 glands per eye. 
 
Per the method described by Korb et al, 30 place the part of the instrument's contact 
surface onto the skin immediately inferior to the eyelashes of the lower eyelid so that 
the long dimension is parallel to the eyelid margin.  Once full contact is achieved 
between the instrument and the skin immediately below the lash line of the lower lid, 
rotate the shaft of the instrument downward approximately 15 to 45 degrees. Then, 
depress the shaft midway (~3mm) and roll the lower eyelid margin slightly outward.   
 
Hold the instrument in place over each third of the lid for a minimum of 10 and a 
maximum of 15 seconds while grading the quality of secretion of the 5 glands in the 
center of the instrument (15 glands total per eye).  Grade the quality of the secretions 
per the following scale described by Lane et al31: 
 
o 0 = nothing 
o 1 = toothpaste 
o 2 = cloudy 
o 3 = clear 
 
From this assessment the following endpoints will be calculated: 
• Total Meibomian Gland Secretion Score:  Sum of the grade (0 – 3) for each of the 
15 glands.  Range for this score is 0-45. 
• Count of the number of Meibomian glands yielding clear liquid secretions.  
Range for this count is 0-15. 
• Count of the number of glands secreting any liquid (clear or cloudy).  Range for 
this count is 0-15. 
 
 
 
30 Korb DR, Blackie CA. Meibomian gland diagnostic expressibility: correlation with dry eye symptoms and 
gland location. Cornea. 2008;27: 1142–1147. 
31 Lane SS, DuBiner H, Epstein RJ, et al;  A New System, the LipiFlow, for the Treatment of Meibomian 
Gland Dysfunction. Cornea. 2012: 31 : 396-404. 

 
 
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21 APPENDIX B - DECLARATION OF HELSINKI 
I. 
PREAMBLE 
 
1. 
The World Medical Association (WMA) has developed the Declaration of 
Helsinki as a statement of ethical principles for medical research involving 
human subjects, including research on identifiable human material and data. 
 
The Declaration is intended to be read as a whole and each of its constituent 
paragraphs should be applied with consideration of all other relevant 
paragraphs. 
 
2. 
Consistent with the mandate of the WMA, the Declaration is addressed 
primarily to physicians. The WMA encourages others who are involved in 
medical research involving human subjects to adopt these principles. 
 
II. 
GENERAL PRINCIPLES 
 
1. 
The Declaration of Geneva of the WMA binds the physician with the words, 
“The health of my patient will be my first consideration,” and the International 
Code of Medical Ethics declares that, “A physician shall act in the patient's best 
interest when providing medical care.” 
 
2. 
It is the duty of the physician to promote and safeguard the health, well-being 
and rights of patients, including those who are involved in medical research. 
The physician's knowledge and conscience are dedicated to the fulfilment of 
this duty. 
 
3. 
Medical progress is based on research that ultimately must include studies 
involving human subjects. 
 
4. 
The primary purpose of medical research involving human subjects is to 
understand the causes, development and effects of diseases and improve 
preventive, diagnostic and therapeutic interventions (methods, procedures 
and treatments). Even the best proven interventions must be evaluated 
continually through research for their safety, effectiveness, efficiency, 
accessibility and quality. 
 
5. 
Medical research is subject to ethical standards that promote and ensure 
respect for all human subjects and protect their health and rights. 
 

 
 
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6. 
While the primary purpose of medical research is to generate new knowledge, 
this goal can never take precedence over the rights and interests of individual 
research subjects. 
7. 
It is the duty of physicians who are involved in medical research to protect the 
life, health, dignity, integrity, right to self-determination, privacy, and 
confidentiality of personal information of research subjects. The responsibility 
for the protection of research subjects must always rest with the physician or 
other health care professionals and never with the research subjects, even 
though they have given consent. 
 
8. 
Physicians must consider the ethical, legal and regulatory norms and standards 
for research involving human subjects in their own countries as well as 
applicable international norms and standards. No national or international 
ethical, legal or regulatory requirement should reduce or eliminate any of the 
protections for research subjects set forth in this Declaration. 
 
9. 
Medical research should be conducted in a manner that minimizes possible 
harm to the environment. 
 
10. Medical research involving human subjects must be conducted only by 
individuals with the appropriate ethics and scientific education, training and 
qualifications. Research on patients or healthy volunteers requires the 
supervision of a competent and appropriately qualified physician or other 
health care professional. 
 
11. Groups that are underrepresented in medical research should be provided 
appropriate access to participation in research. 
 
12. Physicians who combine medical research with medical care should involve 
their patients in research only to the extent that this is justified by its potential 
preventive, diagnostic or therapeutic value and if the physician has good 
reason to believe that participation in the research study will not adversely 
affect the health of the patients who serve as research subjects. 
 
13. Appropriate compensation and treatment for subjects who are harmed as a 
result of participating in research must be ensured. 
 
III. 
RISKS, BURDENS AND BENEFITS 
 
• 
In medical practice and in medical research, most interventions involve risks 
and burdens. 

 
 
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Medical research involving human subjects may only be conducted if the 
importance of the objective outweighs the risks and burdens to the research 
subjects. 
 
• 
All medical research involving human subjects must be preceded by careful 
assessment of predictable risks and burdens to the individuals and groups 
involved in the research in comparison with foreseeable benefits to them and 
to other individuals or groups affected by the condition under investigation. 
 
Measures to minimize the risks must be implemented. The risks must be 
continuously monitored, assessed and documented by the researcher. 
 
• 
Physicians may not be involved in a research study involving human subjects 
unless they are confident that the risks have been adequately assessed and can 
be satisfactorily managed. 
 
When the risks are found to outweigh the potential benefits or when there is 
conclusive proof of definitive outcomes, physicians must assess whether to 
continue, modify or immediately stop the study. 
 
IV. 
VULNERABLE GROUPS AND INDIVIDUALS 
 
• 
Some groups and individuals are particularly vulnerable and may have an 
increased likelihood of being wronged or of incurring additional harm. 
 
All vulnerable groups and individuals should receive specifically considered 
protection. 
 
• 
Medical research with a vulnerable group is only justified if the research is 
responsive to the health needs or priorities of this group and the research 
cannot be carried out in a non-vulnerable group. In addition, this group should 
stand to benefit from the knowledge, practices or interventions that result 
from the research. 
 
V. 
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS 
 
• 
Medical research involving human subjects must conform to generally 
accepted scientific principles, be based on a thorough knowledge of the 
scientific literature, other relevant sources of information, and adequate 
laboratory and, as appropriate, animal experimentation. The welfare of 
animals used for research must be respected. 

 
 
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• 
The design and performance of each research study involving human subjects 
must be clearly described and justified in a research protocol. 
 
The protocol should contain a statement of the ethical considerations involved 
and should indicate how the principles in this Declaration have been 
addressed. The protocol should include information regarding funding, 
sponsors, institutional affiliations, potential conflicts of interest, incentives for 
subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in 
the research study. 
 
In clinical trials, the protocol must also describe appropriate arrangements for 
post-trial provisions. 
 
VI. 
RESEARCH ETHICS COMMITTEES 
 
• 
The research protocol must be submitted for consideration, comment, 
guidance and approval to the concerned research ethics committee before the 
study begins. This committee must be transparent in its functioning, must be 
independent of the researcher, the sponsor and any other undue influence and 
must be duly qualified. It must take into consideration the laws and regulations 
of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to 
reduce or eliminate any of the protections for research subjects set forth in 
this Declaration. 
 
The committee must have the right to monitor ongoing studies. The researcher 
must provide monitoring information to the committee, especially information 
about any serious adverse events. No amendment to the protocol may be 
made without consideration and approval by the committee. After the end of 
the study, the researchers must submit a final report to the committee 
containing a summary of the study’s findings and conclusions. 
 
VII. PRIVACY AND CONFIDENTIALITY 
 
• 
Every precaution must be taken to protect the privacy of research subjects and 
the confidentiality of their personal information. 
 
 

 
 
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VIII. INFORMED CONSENT 
 
• 
Participation by individuals capable of giving informed consent as subjects in 
medical research must be voluntary. Although it may be appropriate to consult 
family members or community leaders, no individual capable of giving 
informed consent may be enrolled in a research study unless he or she freely 
agrees. 
 
• 
In medical research involving human subjects capable of giving informed 
consent, each potential subject must be adequately informed of the aims, 
methods, sources of funding, any possible conflicts of interest, institutional 
affiliations of the researcher, the anticipated benefits and potential risks of the 
study and the discomfort it may entail, post-study provisions and any other 
relevant aspects of the study. The potential subject must be informed of the 
right to refuse to participate in the study or to withdraw consent to participate 
at any time without reprisal. Special attention should be given to the specific 
information needs of individual potential subjects as well as to the methods 
used to deliver the information. 
 
After ensuring that the potential subject has understood the information, the 
physician or another appropriately qualified individual must then seek the 
potential subject’s freely-given informed consent, preferably in writing. If the 
consent cannot be expressed in writing, the non-written consent must be 
formally documented and witnessed. 
 
All medical research subjects should be given the option of being informed 
about the general outcome and results of the study. 
 
• 
When seeking informed consent for participation in a research study the 
physician must be particularly cautious if the potential subject is in a 
dependent relationship with the physician or may consent under duress. In 
such situations the informed consent must be sought by an appropriately 
qualified individual who is completely independent of this relationship. 
 
• 
For a potential research subject who is incapable of giving informed consent, 
the physician must seek informed consent from the legally authorized 
representative. These individuals must not be included in a research study that 
has no likelihood of benefit for them unless it is intended to promote the 
health of the group represented by the potential subject, the research cannot 
instead be performed with persons capable of providing informed consent, and 
the research entails only minimal risk and minimal burden. 
 

 
 
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• 
When a potential research subject who is deemed incapable of giving informed 
consent is able to give assent to decisions about participation in research, the 
physician must seek that assent in addition to the consent of the legally 
authorized representative. The potential subject’s dissent should be respected. 
 
• 
Research involving subjects who are physically or mentally incapable of giving 
consent, for example, unconscious patients, may be done only if the physical or 
mental condition that prevents giving informed consent is a necessary 
characteristic of the research group. In such circumstances the physician must 
seek informed consent from the legally authorized representative. If no such 
representative is available and if the research cannot be delayed, the study 
may proceed without informed consent provided that the specific reasons for 
involving subjects with a condition that renders them unable to give informed 
consent have been stated in the research protocol and the study has been 
approved by a research ethics committee. Consent to remain in the research 
must be obtained as soon as possible from the subject or a legally authorized 
representative. 
 
• 
The physician must fully inform the patient which aspects of their care are 
related to the research. The refusal of a patient to participate in a study or the 
patient’s decision to withdraw from the study must never adversely affect the 
patient-physician relationship. 
 
• 
For medical research using identifiable human material or data, such as 
research on material or data contained in biobanks or similar repositories, 
physicians must seek informed consent for its collection, storage and/or reuse. 
There may be exceptional situations where consent would be impossible or 
impracticable to obtain for such research. In such situations the research may 
be done only after consideration and approval of a research ethics committee. 
 
IX. 
USE OF PLACEBO 
 
• 
The benefits, risks, burdens and effectiveness of a new intervention must be 
tested against those of the best proven intervention(s), except in the following 
circumstances: 
 
Where no proven intervention exists, the use of placebo, or no intervention, is 
acceptable; or 
 
Where for compelling and scientifically sound methodological reasons the use 
of any intervention less effective than the best proven one, the use of placebo, 

 
 
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or no intervention is necessary to determine the efficacy or safety of an 
intervention 
 
and the patients who receive any intervention less effective than the best 
proven one, placebo, or no intervention will not be subject to additional risks 
of serious or irreversible harm as a result of not receiving the best proven 
intervention. 
 
Extreme care must be taken to avoid abuse of this option. 
 
X. 
POST-TRIAL PROVISIONS 
 
• 
In advance of a clinical trial, sponsors, researchers and host country 
governments should make provisions for post-trial access for all participants 
who still need an intervention identified as beneficial in the trial. This 
information must also be disclosed to participants during the informed consent 
process. 
 
XI. 
RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS 
 
• 
Every research study involving human subjects must be registered in a publicly 
accessible database before recruitment of the first subject. 
 
• 
Researchers, authors, sponsors, editors and publishers all have ethical 
obligations with regard to the publication and dissemination of the results of 
research. Researchers have a duty to make publicly available the results of 
their research on human subjects and are accountable for the completeness 
and accuracy of their reports. All parties should adhere to accepted guidelines 
for ethical reporting. Negative and inconclusive as well as positive results must 
be published or otherwise made publicly available. Sources of funding, 
institutional affiliations and conflicts of interest must be declared in the 
publication. Reports of research not in accordance with the principles of this 
Declaration should not be accepted for publication. 
 
XII. UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE 
 
In the treatment of an individual patient, where proven interventions do not exist 
or other known interventions have been ineffective, the physician, after seeking 
expert advice, with informed consent from the patient or a legally authorized 
representative, may use an unproven intervention if in the physician's judgment it 
offers hope of saving life, re-establishing health or alleviating suffering. This 
intervention should subsequently be made the object of research, designed to 

 
 
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evaluate its safety and efficacy. In all cases, new information must be recorded 
and, where appropriate, made publicly available.