A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)
Phase: NA
Conditions: Dry Eye
Sponsor: Sight Sciences, Inc.

PILOT STUDY OF THE TEARCARETM SYSTEM 
CURRENT REVISION: 
Rev C 
REVISION DATE: 
July 28, 2017 
SPONSOR: 
Sight Sciences, Inc. 
3000 Sand Hill Road 
Building 3, Suite 105 
Men o Park, CA  94025 
877-266-1144
Agreement of Principal Investigato
I,  
  agree to conduct this trial in accordance 
with this clinical protocol and any amendments. 
Signature 
Date 
Cen er 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. 
Do not copy or distribute without written permission. 
o
Do
 
NCT03006978
PROTOCOL ID #:  05429

 
 
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1 REVISION HISTORY 
Revision 
Date Issued 
 
 
 
 
C 
July 28, 2017 
 

 
 
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2 PROTOCOL SYNOPSIS 
Protocol Title 
Pilot Study of the TearCareTM System 
Protocol ID Number 
 
Study Device 
TearCareTM System 
Intended 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 of adult patients. Such applications would include 
Meibomian Gland Dysfunction (MGD), Dry Eye, 
Blepharitis, Stye, or Chalazia. 
Control Device 
MGDRx® EyeBag® reusable warm compress 
Primary Objective 
Evaluate the clinical utility, safety, and effectiveness of the 
TearCare™ System compared to standardized warm 
compress therapy for the application of controlled, 
localized heat therapy in adult patients with dry eye 
syndrome. 
Study Design 
Single center, prospective, randomized, controlled trial. 
Primary Effectiveness 
Endpoint 
Tear Breakup Time at 4 weeks 
Secondary Effectiveness 
Endpoints 
• Meibomian Gland (MG) Assessment: 
o # Glands yielding clear liquid secretions 
o # Glands secreting any liquid 
o Total MG Score 
• Dry Eye Symptoms and Quality of Life as measured by: 
o Standard Patient Evaluation of Eye Dryness 
(SPEED) Questionnaire 
o Ocular Surface Disease Index (OSDI) 
Questionnaire 
o Symptom Assessment in Dry Eye (SANDE) 
Questionnaire 
o Dry Eye Symptom Burden Tool, Activity 
Interference domain 
• Change in use of dry eye medications or lubricant 
Safety Endpoints 
• Device-related adverse events 
• Corneal & conjunctival staining scores 
• IOP by Goldmann tonometry 
• Best spectacle-corrected Snellen visual acuity 

 
 
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Inclusion Criteria 
1. At least 18 years of age 
2. Reports dry eye symptoms within 3 months of the 
screening examination with a Standard Patient 
Evaluation for Dryness (SPEED) score ≥ 6 
3. Schirmer 1 value of ≤10 mm in at least one eye or a 
TBUT of <10 seconds in at least one eye 
4. Willing to comply with the study, procedures, and 
follow-up 
5. Willing and able to provide consent 

 
 
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Exclusion Criteria 
1. 
Any active ocular or peri-ocular infection or 
inflammation 
2. 
Recurrent eye inflammation within the past 3 months 
3. 
Ocular surgery, oculoplastic surgery, ocular injury, 
Ocular Herpes Simplex, or Herpex Zoster 
4. 
Ocular surface abnormalities that may affect tear film 
distribution or treatment 
5. 
Abnormal eyelid function in either eye 
6. 
Diminished or abnormal facial, periocular, ocular or 
corneal sensation 
7. 
Ocular surface abnormalities such as corneal epithelial 
defects, ulcers, corneal dystrophies 
8. 
Systemic diseases resulting in dry eye (e.g. Sjogren’s 
syndrome) 
9. 
Allergies to silicone tissue adhesives 
10. An absence or fibrosis of the Meibomian glands (e.g. 
ectodermal dysplasia). 
11. Unwillingness to abstain for the duration of the study 
from systemic medication known to cause ocular 
dryness (e.g. Accutane, antihistamines, etc.) 
12. Anyone who requires chronic use (i.e. for any portion 
of the study) of  topical ophthalmic antibiotics, 
steroids, non-steroidal anti-inflammatory medications 
or who has been on any of these medications within 
the past 30 days. 
13. Unwillingness to washout and remain off the dry eye 
medications listed in Table 3 for the duration of the 
study. 
14. Participation in another ophthalmic clinical trial within 
the past 30 days 
15. Co-existing conditions that could interfere with the 
assessment of safety or efficacy of treatment (e.g. 
macular disease, pregnancy, nursing, etc.) 
Study Duration for Each 
Subject 
6 months 
Proposed Duration of 
Study 
8 months 
Schedule of Visits 
Screening, Baseline/Treatment, 1 Day, 2 weeks, 4 weeks, 3 
month, 6 months 
Number of Centers 
1 

 
 
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Number of Subjects 
24 
Randomization 
1:1 
Study Extension 
Subjects randomized to TearCare will be given the option 
of extending their participation in the study for an 
additional 6 months.  If they choose to participate, they 
will be re-treated with the TearCare System at the Study 
Extension Baseline Visit and then will have follow-up visits 
at 1, 3 and 6 months following re-treatment. 
 
 
 

 
 
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3 TABLE OF CONTENTS 
1 
REVISION HISTORY .......................................................................................................................... 2 
2 
PROTOCOL SYNOPSIS ...................................................................................................................... 3 
3 
TABLE OF CONTENTS ....................................................................................................................... 7 
4 
STUDY OBJECTIVE ......................................................................................................................... 10 
5 
BACKGROUND AND JUSTIFICATION FOR THE STUDY .................................................................... 10 
6 
DESCRIPTION OF DEVICE ............................................................................................................... 13 
6.1 
INTENDED USE .................................................................................................................................... 13 
6.2 
DEVICE DESCRIPTION ........................................................................................................................... 13 
6.2.1 
Manufacturing & Traceability of device ............................................................................... 14 
6.3 
INSTRUCTIONS FOR USE ........................................................................................................................ 14 
6.4 
SUMMARY OF THE TRAINING AND EXPERIENCE NEEDED FOR USE OF DEVICE UNDER INVESTIGATION ................... 14 
6.5 
DESCRIPTION OF ASSOCIATED MEDICAL OR SURGICAL PROCEDURES .............................................................. 14 
7 
PRIOR INVESTIGATIONS ................................................................................................................ 14 
7.1 
PRECLINICAL TESTING ........................................................................................................................... 14 
7.2 
PREVIOUS CLINICAL EXPERIENCE ............................................................................................................ 15 
8 
STUDY ENDPOINTS........................................................................................................................ 16 
8.1 
EFFECTIVENESS ENDPOINTS ................................................................................................................... 16 
8.2 
SAFETY ENDPOINTS.............................................................................................................................. 17 
8.3 
SATISFACTION WITH DRY EYE TREATMENT ............................................................................................... 18 
9 
STUDY DESIGN .............................................................................................................................. 18 
9.1 
STUDY DEVICE AND COMPARATOR ......................................................................................................... 18 
10 
STUDY SELECTION CRITERIA .......................................................................................................... 18 
10.1 
INCLUSION CRITERIA ....................................................................................................................... 18 
10.2 
EXCLUSION CRITERIA ....................................................................................................................... 18 
11 
STUDY PROCEDURES ..................................................................................................................... 19 
11.1 
STUDY SCHEDULE ........................................................................................................................... 19 
11.2 
NUMBER OF SUBJECTS AND STUDY DURATION ..................................................................................... 20 
11.3 
DURATION OF USE/FOLLOW-UP ....................................................................................................... 20 
11.4 
MATERIAL AND EQUIPMENT ............................................................................................................. 21 
11.5 
INFORMED CONSENT AND POINT OF ENROLLMENT ............................................................................... 21 
11.6 
SCREENING VISIT ............................................................................................................................ 22 
11.6.1 
Dry Eye Medication Washout ........................................................................................... 22 
11.7 
BASELINE VISIT .............................................................................................................................. 22 
11.7.1 
Baseline Exams and Questionnaires ................................................................................ 22 
11.7.2 
Randomization ................................................................................................................. 23 
11.7.3 
Treatment for TearCare Group ........................................................................................ 23 
11.7.4 
Treatment for Warm Compress Group ............................................................................ 24 
11.8 
FOLLOW-UP .................................................................................................................................. 24 
11.8.1 
Management of Dry Eye Symptoms During Follow-Up .................................................... 25 
11.9 
STUDY EXTENSION (TEARCARE ONLY) ................................................................................................ 25 
11.9.1 
Study Extension Informed Consent .................................................................................. 26 

 
 
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11.9.2 
Study Extension Baseline Visit .......................................................................................... 26 
11.9.2.1 
Baseline Exams and Questionnaires .......................................................................................... 26 
11.9.2.2 
TearCare Treatment ................................................................................................................... 27 
11.9.3 
Study Extension Follow-Up ............................................................................................... 27 
11.10 
WITHDRAWAL AND DISCONTINUATION ............................................................................................... 27 
12 
ADVERSE EVENTS (AES) ................................................................................................................. 28 
12.1 
DEFINITIONS OF AE, SAE, SADE, USADE .......................................................................................... 28 
12.2 
LIST OF ANTICIPATED ADVERSE EVENTS .............................................................................................. 29 
12.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS ........................................... 29 
13 
RISK-BENEFIT ANALYSIS ................................................................................................................ 30 
13.1 
ANTICIPATED CLINICAL BENEFITS ........................................................................................................ 30 
13.2 
ANTICIPATED ADVERSE DEVICE EFFECTS ............................................................................................... 30 
13.3 
RESIDUAL RISKS ASSOCIATED WITH THE INVESTIGATIONAL DEVICE, AS IDENTIFIED IN THE RISK ANALYSIS REPORT . 30 
13.4 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION ................................................... 30 
13.5 
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS ....................................................... 31 
13.6 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ............................................................. 31 
13.7 
RISK-TO-BENEFIT RATIONALE ............................................................................................................ 32 
14 
STATISTICAL CONSIDERATIONS ..................................................................................................... 32 
14.1 
HYPOTHESIS .................................................................................................................................. 32 
14.2 
SAMPLE SIZE CALCULATION .............................................................................................................. 32 
14.3 
PASS/FAIL CRITERIA ........................................................................................................................ 32 
14.4 
STATISTICAL DESIGN, METHOD & ANALYTICAL PROCEDURES TO BE USED .................................................. 33 
14.5 
INTERIM ANALYSIS AND EARLY TERMINATION CRITERIA .......................................................................... 33 
14.6 
DEVIATION FROM THE STATISTICAL PLAN ............................................................................................ 33 
14.7 
SUB-GROUP ANALYSES .................................................................................................................... 33 
14.8 
ACCOUNTING FOR ALL DATA ............................................................................................................ 33 
15 
MONITORING PROCEDURES ......................................................................................................... 33 
15.1 
MONITORING TO BE CONDUCTED DURING THE INVESTIGATION ................................................................ 33 
15.2 
EXTENT OF SOURCE DATA VERIFICATION ............................................................................................. 34 
16 
DATA AND QUALITY MANAGEMENT ............................................................................................. 34 
16.1 
DATABASE MANAGEMENT ............................................................................................................... 34 
16.2 
RETENTION PERIOD......................................................................................................................... 34 
17 
PROTOCOL MODIFICATIONS AND DEVIATIONS ............................................................................. 34 
18 
DEVICE FAILURES AND MALFUNCTIONS ........................................................................................ 35 
19 
STATEMENTS OF COMPLIANCE ..................................................................................................... 35 
20 
STUDY ADMINISTRATION ............................................................................................................. 35 
20.1 
DEVICE ACCOUNTABILITY ................................................................................................................. 35 
20.2 
EARLY TERMINATION OR SUSPENSION OF AN INVESTIGATION .................................................................. 35 
20.3 
INVESTIGATOR RESPONSIBILITIES ....................................................................................................... 36 
20.3.1 
General Responsibilities of Investigators ......................................................................... 36 
20.3.2 
Specific Responsibilities of Investigators .......................................................................... 36 
20.3.3 
Investigator Records ........................................................................................................ 36 
20.3.4 
Investigator Reports ......................................................................................................... 37 
20.4 
INVESTIGATOR AGREEMENT .............................................................................................................. 37 

 
 
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21 
ASSOCIATED DOCUMENTS ............................................................................................................ 38 
22 
PUBLICATION POLICY .................................................................................................................... 38 
23 
BIBLIOGRAPHY .............................................................................................................................. 38 
24 
APPENDIX A – METHODS FOR OCULAR EXAMS AND TESTS AND ADMINISTRATION OF 
QUESTIONNAIRES .................................................................................................................................. 41 
24.1 
EYE EXAM ..................................................................................................................................... 41 
24.2 
MEIBOMIAN GLAND ASSESSMENT ..................................................................................................... 41 
24.3 
TEAR BREAKUP TIME (TBUT) ........................................................................................................... 41 
24.4 
SCHIRMER TEST.............................................................................................................................. 42 
24.5 
CORNEAL AND CONJUNCTIVAL STAINING ............................................................................................. 42 
24.6 
VISUAL ACUITY .............................................................................................................................. 43 
24.7 
SPEED QUESTIONNAIRE .................................................................................................................. 43 
24.8 
OSDI QUESTIONNAIRE .................................................................................................................... 43 
24.9 
SANDE QUESTIONNAIRE ................................................................................................................. 43 
24.10 
DRY EYE SYMPTOM BURDEN TOOL .................................................................................................... 44 
24.11 
SATISFACTION QUESTIONNAIRE ......................................................................................................... 44 
25 
DECLARATION OF HELSINKI ........................................................................................................... 45 
 
 
 
 

 
 
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4 STUDY OBJECTIVE 
The objective of this pilot study is to evaluate the clinical utility, safety, and 
effectiveness of the TearCare™ System compared to standardized warm compress 
therapy for the application of controlled, localized heat therapy in adult patients with 
dry eye syndrome. 
5 BACKGROUND AND JUSTIFICATION FOR THE STUDY 
Dry Eye Syndrome 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.  It is approximated that 23 million people over age 20 suffer from dry eye 
in the U.S. 
 
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. For an individual 
patient, the annual direct cost ranges from $678 per year for mild cases to $1,200 
annually for severe cases.  Moreover, there is a great cost to society in terms of 
decreased productivity due to the symptoms of dry eye. Essentially, not only do dry eye 
patients directly suffer, but there is also a burden to healthcare, employers, and society. 
 
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 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, including those associated with dry 
eye. 
 
 
 
 
 
 
 
 

 
 
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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 
evaporative dry eye syndrome.3,4,5,6  It is estimated that evaporative dry eye syndrome 
accounts for 65-85% of dry eye cases.  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 evaporative dry eye.7  When 
this occurs, it can result in ocular discomfort and, in many cases, ocular surface 
disorders that can affect vision.   
 
One of the most commonly prescribed treatments for evaporative dry eye and 
meibomian gland dysfunction is the use of warm compresses. It is believed that the heat 
from warm compresses helps melt the oily obstructions in the meibomian glands and 
helps reduce gland inflammation, thereby helping to restore the ability of the 
meibomian glands to effectively secrete oil onto the tear film and prevent rapid tear 
evaporation.   It has been shown that warm compress therapy can lead to improved 
lipid production and flow on to the tear film.8,9,10  This improved lipid delivery is 
associated not only with an improvement in the profile of the tear film but also an 
improvement in patient symptoms.11,12,13  The tear film is demonstrably thicker and 
more stable with an increased contribution of lipid to its surface.14,15,16  However, many 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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factors contribute to poor penetration of warm compress therapy in the dry eye 
population. More specifically, warm compress therapy has failed to achieve widespread 
acceptance among patients because: 
 
• It is inconvenient and disruptive to a patent’s schedule 
• The temperature necessary to achieve an effective AND safe compress is 
difficult to achieve and maintain at home17,18,19 
• Warm compresses, when used at home, tend to cool quickly thereby 
diminishing their efficacy 
• Some patients may over heat the compress putting them at risk for injury20,21 
• Patients are not able to enhance the effect by expressing molten secretions 
from their meibomian glands as a physician routinely does for his/her 
patients. 
Various approaches to heating the eyelids have been proposed, but often they may be 
too cumbersome or costly for patients.22,23,24,25,26 
 
Sight Sciences has developed a novel device, the TearCare™ System, to deliver 
controlled, precise heat to the meibomian glands for 12 minutes in the monitored 
setting of an ophthalmologist or optometrist office.  (Refer to Section 6, Description of 
Device, below.)  The TearCare session is then followed by routine manual expression of 
the meibomian glands by the physician. The goal of this is to more effectively and 
conveniently treat dry eye with an accepted proven treatment.   
 
This pilot study is being conducted in order to: 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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a) Provide data to assist with sample size calculations for a future pivotal study 
b) Exercise study protocol, procedures, case report forms and data management 
and to identify areas for their improvement 
c) Collect device safety data 
d) Provide usability feedback on the use of the device 
e) Collect data regarding the efficacy of the device 
6 DESCRIPTION OF DEVICE 
6.1 INTENDED 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 of adult patients. Such applications would include Meibomian Gland Dysfunction 
(MGD), Dry Eye, Blepharitis, Stye, or Chalazia. 
6.2 DEVICE DESCRIPTION 
The TearCareTM System is comprised of the following components: 
 
• iLidTM Device, single unit (05118) or iLid Device, 10 Pack (05346) 
• TearCare System (05031), which includes the following: 
o Controller 
o Charging nest 
o Charging adapter 
o Clip 
 
The TearCare System warms the eyelids, heating them to approximately 43°C.  A 
complete TearCare session lasts 12 minutes.  Heat is applied to the external or 
cutaneous surface of the eyelids via the iLid devices that are powered by the controller. 
The TearCare System is capable of warming the eyelids of one eye or both eyes at a 
time.  Subjects are able to blink naturally during the 12-minute session. 
The inner surface of the iLid devices features a medical grade adhesive, which allows 
them to be affixed to the external surface of the eyelids during the procedure. The iLid 
devices feature temperature controlled, flexible, self-adhering pads that warm the 
eyelid. The iLid devices are disposable and are for single use only.  The iLid devices are 
connected to the controller via a cable.  

 
 
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The controller includes two receptacles, one for each iLid cable connector. Additionally, 
it includes an intuitive interface, temperature control processors, a rechargeable 
battery, and it acts as a power source for the iLid devices.   
The system is operated by a healthcare provider who affixes the iLid device(s) to the 
patient’s eyelid(s), initiates the session, and may adjust the system warmth level before 
or during a session.   
6.2.1 
MANUFACTURING & TRACEABILITY OF DEVICE 
The TearCare System is manufactured for Sight Sciences Inc. by a contract 
manufacturer.  The iLid Devices are provided non-sterile and are for single use only.  
They are identified by lot numbers. 
 
 
 
6.3 INSTRUCTIONS FOR USE 
Instructions for Use are provided with each TearCare System. 
6.4 SUMMARY OF THE TRAINING AND EXPERIENCE NEEDED FOR USE OF 
DEVICE UNDER INVESTIGATION 
This is a single-center study, conducted by Dr. David Badawi.  Dr. Badawi is a co-inventor 
of the TearCare System and is familiar with its proper use.  He will review the 
Instructions for Use in advance of initiating the investigation. 
6.5 DESCRIPTION OF ASSOCIATED MEDICAL OR SURGICAL PROCEDURES 
Within 10 minutes following the 12-minute TearCare session, the investigator will 
perform manual Meibomian gland expression of all 4 eyelids under topical anesthesia 
with ophthalmic tetracaine 0.5% drops. 
7 PRIOR INVESTIGATIONS 
7.1 PRECLINICAL TESTING 
The TearCare System has been tested extensively on the bench to demonstrate that it 
meets all specified safety and performance requirements.  The following testing and 
analyses was performed: 
 

 
 
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• Thermal Requirements:  Testing was performed to demonstrate that the 
TearCare System meets the minimum, maximum and nominal therapeutic 
temperature requirements. 
• Software Functionality:  Testing was performed to demonstrate that the 
software in the TearCare Controller and iLid Devices meet all software 
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 they system 
meets mechanical strength requirements. 
• Shipping, Storage, and Shelf-Life Testing:  Testing was performed to demonstrate 
that the TearCare System meets shipping, storage and shelf-life requirements. 
 
The TearCare System passed all pre-clinical testing, demonstrating that they system 
meets its requirements. 
7.2 PREVIOUS CLINICAL EXPERIENCE 
Clinical Trial with a Prototype TearCare System 
 
A prototype version of the TearCare System was tested in a feasibility study with a 
similar study design (Aspire protocol ID 040113).  The study enrolled 30 subjects who 
were randomized to two treatment arms:  (a) a prototype TearCare System, or (b) warm 
compress treatment.  Subjects randomized to the TearCare arm (n=20) received one, 
10-minute TearCare session followed by manual expression of the Meibomian glands.  
Subjects randomized to the warm compress arm (n=16) received standard warm 
compress therapy (5 minutes/day for 2 weeks).  Subjects were enrolled for 4 weeks, 
with follow-up visits at 1 day, 2 weeks, and 4 weeks.   
 
No adverse events were reported in this study.  Table 1 presents the results from the 
endpoints evaluated in this study. 
 

 
 
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Table 1:  Prototype TearCare System Pilot Study Results 
 
 
 
This feasibility study demonstrated the safety of the TearCare System and provided 
evidence that TearCare System is effective in improving Meibomian gland secretions, 
reducing tear break-up time, and reducing the symptoms of dry eye. 
8 STUDY ENDPOINTS 
8.1 EFFECTIVENESS ENDPOINTS 
The primary effectiveness endpoint of the study is the change from baseline to 4 weeks 
in Tear Break-Up Time (TBUT) in the TearCare group versus the warm compress group. 
 
Secondary effectiveness endpoints include the change from baseline to follow-up in the 
TearCare group vs. the warm compress group in the following: 
 

 
 
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• Meibomian Gland Assessment27 scores for the following: 
o The number of Meibomian glands yielding clear liquid secretions (grade 
3) 
o The number of glands secreting any liquid (clear or cloudy with grade 2 or 
3) 
o The total Meibomian Gland Score 
• Dry Eye Symptoms and Quality of Life, as measured by: 
o The Standard Patient Evaluation of Dry Eye (SPEED) II questionnaire28, 
which measures the severity and frequency of dry eye symptoms 
o Ocular Surface Disease Index (OSDI) Questionnaire29.  The OSDI consists 
of 12 questions to assess ocular symptoms (the Ocular Symptoms 
subscale), their impact on patient vision-related functioning (Vision 
Related Function subscale), and environmental factors triggering the 
symptoms (Environmental Triggers subscale). 
o Symptom Assessment in Dry Eye (SANDE) Questionnaire.30, 31  The SANDE 
is a 2-question survey which uses a visual analog scale to assess the 
frequency and severity of dry eye symptoms 
o Dry Eye Symptom Burden Tool32, Activity Interference domain, which 
measures how dry eye symptoms impact how the subject feels. 
• Change in use of dry eye medications or lubricant 
8.2 SAFETY ENDPOINTS 
Safety of the TearCare System will be evaluated by evaluating changes in the following 
measures: 
 
• Device-related adverse events 
• Corneal & conjunctival staining scores 
• IOP by Goldmann tonometry 
• Best spectacle-corrected Snellen visual acuity 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 

 
 
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8.3 SATISFACTION WITH DRY EYE TREATMENT 
Satisfaction with the TearCare treatment will be assessed using a questionnaire 
modeled after the one developed by Schaumberg, et al.33 
9 STUDY DESIGN 
This is a prospective, randomized, single-center treatment study.  No specific attempts 
will be made for minimization of bias, such as blinding or masking. 
9.1 STUDY DEVICE AND COMPARATOR 
In this study, TearCare treatment will be compared with standard warm compress 
treatment.  Warm compress treatment was chosen as the comparator since it is one of 
the most commonly prescribed treatments for evaporative dry eye and meibomian 
gland dysfunction.  The MGDRx EyeBag® (The EyeBag Company Ltd.), a reusable warm 
compress, will be used for the warm compress control group.  
10 STUDY SELECTION CRITERIA 
10.1 INCLUSION CRITERIA 
For inclusion in this study, subjects must meet all of the following criteria: 
 
1. At least 18 years of age 
2. Reports dry eye symptoms within 3 months of the screening examination with a 
Standard Patient Evaluation for Dryness (SPEED) score ≥ 6 
3. Schirmer 1 value of ≤10 mm in at least one eye or a TBUT of <10 seconds in at 
least one eye 
4. Willing to comply with the study, procedures, and follow-up 
5. Willing and able to provide consent 
10.2 EXCLUSION CRITERIA 
A subject who meets any of the criteria listed below will be excluded from the study: 
 
1. Any active ocular or peri-ocular infection or inflammation 
2. Recurrent eye inflammation within the past 3 months 
 
 
 

 
 
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3. Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or 
Herpex Zoster 
4. Ocular surface abnormalities that may affect tear film distribution or treatment 
5. Abnormal eyelid function in either eye 
6. Diminished or abnormal facial, periocular, ocular or corneal sensation 
7. Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal 
dystrophies 
8. Systemic diseases resulting in dry eye (e.g. Sjogren’s syndrome) 
9. Allergies to silicone tissue adhesives 
10. An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia). 
11. Unwillingness to abstain for the duration of the study from systemic medication 
known to cause ocular dryness (e.g. Accutane, antihistamines, etc.) 
12. Anyone who requires chronic use (i.e. for any portion of the study) of  topical 
ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or 
who has been on any of these medications within the past 30 days. 
13. Unwillingness to washout and remain off the dry eye medications listed in Table 
3 for the duration of the study. 
14. Participation in another ophthalmic clinical trial within the past 30 days 
15. Co-existing conditions that could interfere with the assessment of safety or 
efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.) 
11 STUDY PROCEDURES 
11.1 STUDY SCHEDULE 
An overview of all the study procedures is provided in the Study Schedule shown below 
in Table 2. 
 

 
 
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Warm Compress Treatment and will then continue to use the Warm compress at home 
for 5 minutes a day for 2 weeks.  Subjects in the Warm Compress group will be required 
to keep a log to document their daily warm compress treatment. 
 
All subjects will be followed for 6 months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.5 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 screening evaluation.  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. 

 
 
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• Whose Baseline Visit is performed between 0-7 days from the time of the 
Screening visit. 
 
At the Baseline Visit, subjects should first undergo the following tests and exams to 
confirm that they still meet the Subject Selection Criteria following washout from ocular 
medications, if applicable, and to record baseline data: 
 
• Medical history 
• Medication use: ocular and systemic 
• Ocular History 
• Questionnaires:  SPEED, OSDI, SANDE, Dry Eye Symptom Burden Tool 
• Best spectacle-corrected Snellen visual acuity 
• Tear Breakup Time 
• Corneal and conjunctival staining score 
• Slit Lamp Exam 
• Schirmer 1 Test 
• Meibomian Gland Assessment 
• IOP (Goldmann) 
After all baseline measurements have been obtained and it has been confirmed that the 
subject meets all the Subject Selection Criteria, then the subject will be randomized to 
receive either TearCare therapy or Warm Compress therapy. 
11.7.2 RANDOMIZATION 
Subjects will be randomized to either the TearCare (i.e. “treatment group”) or Warm 
Compress  (i.e. “control group”) using a pseudo-random number generator with subjects 
enrolled according to a predetermined list. The investigational site will be provided a set 
of envelopes with randomization assignments.  Following randomization, the subject 
should immediately undergo the designated in-office treatment.   
11.7.3 TREATMENT FOR TEARCARE GROUP 
Subjects randomized the TearCare Group will undergo the following procedure: 
 
1. If the subject is currently wearing contact lenses, instruct them to remove the 
lenses prior to starting the treatment. 
2. Obtain a new set of iLid devices and a TearCare Controller with enough battery 
left for at least one treatment.  
3. Wipe the subject’s eyelids and temple with a makeup removal wipe or alcohol 
wipe and allow the skin to dry.  Use care not to allow us any of the wipe to get 
into the eye. 
4. Place a pair of iLid devices on the subject’s eyelids and affix the temple housing 
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5. Connect the iLid devices to the Controller. 
6. Start TearCare treatment.  Adjust the temperature setting on the TearCare 
controller, as necessary, so that it is comfortable for the subject.  The treatment 
session will last for 12 minutes.  Instruct the subject that they can blink naturally 
during the treatment session. 
7. 
 
 
 
 
 
 
 
 
 
 
 
11.7.4 TREATMENT FOR WARM COMPRESS GROUP 
Subjects randomized the Warm Compress Group will undergo the following procedures: 
 
1. Obtain a new MGDRx® EyeBag® warm compress mask.  Unwrap it and place it in 
a microwave for 15 seconds, as per the manufacturer’s instructions.  
2. After verifying that the mask is not hot to touch, place the warm mask over the 
subject’s eyelids for 5 minutes. 
3. After 5 minutes, remove the warm compress. 
4. Instruct the subject how to perform the procedure at home.  Instruct the subject 
to perform the procedure daily for two weeks. 
5. Provide the subject with a log sheet to indicate successful treatment with a 
compress. This will include date and time of compress treatment. Instruct the 
subject to bring this log with them at the 2 week follow-up visit. 
6. The subject will continue daily 5-minute warm compresses at home using the 
same new heating mask that was used for the initial in-office treatment. This will 
continue for 4 weeks. 
11.8 FOLLOW-UP 
Follow-up procedures will be performed per the Study Schedule provided in Section 
11.1 and the methods included in Appendix A.   
 

 
 
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11.8.1 MANAGEMENT OF DRY EYE SYMPTOMS DURING FOLLOW-UP 
Both groups (treatment and control) should be treated consistently. In general, the 
primary consideration for dry eye symptoms is the health of the cornea and the comfort 
of the subject.  
 
Subjects are free to use their over-the-counter lubricants.  For subject safety and 
comfort, a change in medical therapy may be implemented at any time during the study 
at the Investigator’s discretion in the event it is required. The primary concern of the 
Investigator and Sponsor at all times is the health and safety of the subjects.  
 
Medication and lubricants usage will be recorded at each visit. 
11.9 STUDY EXTENSION (TEARCARE ONLY) 
In order to evaluate the safety and effectiveness of re-treatment with the TearCare 
System, at the completion of the study, subjects who were randomized to the TearCare 
group will be given the opportunity to enroll in an extension of the study.  If they elect 
to enroll in the study extension, their participation will be extended another 6 months.  
Extension of the study is anticipated to extend the overall study duration to a total of 
14-15 months. 
 
 
 
 

 
 
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11.9.1 STUDY EXTENSION INFORMED CONSENT 
The IRB-approved informed consent for the study extension will be presented and 
explained to each prospective subject by the investigator.  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 the subject can then proceed 
with the study extension 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 must retain the original, signed written Informed Consent 
Document.  A copy of the written Informed Consent Document must be given to the 
subject. 
11.9.2 STUDY EXTENSION BASELINE VISIT 
11.9.2.1 
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 Visit column of Table 4 
should be performed.  Refer to Appendix A for instructions for performing the exams 
and administering the questionnaires. 
 
At the Baseline Visit, subjects should first undergo the following tests and exams to 
confirm that they still meet the Subject Selection Criteria and to record baseline data: 
 
• Medication use: ocular and systemic 
• Ocular History 
• Questionnaires:  SPEED, OSDI, SANDE 
• Best spectacle-corrected Snellen visual acuity 
• Tear Breakup Time 
• Corneal and conjunctival staining score 
• Slit Lamp Exam 
• Meibomian Gland Assessment 
After all baseline measurements have been obtained, the PI will confirm that the subject 
does not meet any of the Subject Exclusion Criteria listed in Section 10.2.  Then the 
subject will be receive the TearCare treatment. 

 
 
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11.9.2.2 
TEARCARE TREATMENT 
Subjects will undergo the following procedure: 
 
1. If the subject is currently wearing contact lenses, instruct them to remove the 
lenses prior to starting the treatment. 
2. Obtain a new set of iLid devices and a TearCare Controller with enough battery 
left for at least one treatment.  
3. Wipe the subject’s eyelids and temple with a makeup removal wipe or alcohol 
wipe and allow the skin to dry.  Use care not to allow us any of the wipe to get 
into the eye. 
4. Place a pair of iLid devices on the subject’s eyelids and affix the temple housing 
to the subject’s temple. 
5. Connect the iLid devices to the Controller. 
6. Start TearCare treatment.  Adjust the temperature setting on the TearCare 
controller, as necessary, so that it is comfortable for the subject.  The treatment 
session will last for 12 minutes.  Instruct the subject that they can blink naturally 
during the treatment session. 
7. Following TearCare treatment, remove the iLid devices from the subject and 
position the subject at the slit lamp. 
8. Apply 1 drop of tetracaine into each eye.   Using meibomian gland expression 
forceps, express the meibomian glands in all 4 eyelids. 
9. Evaluate the subject for any adverse events. 
10. If the subject was wearing contact lenses, instruct them to wait 30 minutes 
before putting them back in their eyes. 
11.9.3 STUDY EXTENSION FOLLOW-UP 
Follow-up procedures will be performed per the Study Schedule provided in Table 4 and 
the methods included in Appendix A.   
11.10 
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 
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 End of Study Form.   
 
If a subject withdraws from the study prior to receiving the TearCare or Warm Compress 
treatment, then that subject may be replaced in the study by a newly enrolled subject. 

 
 
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12 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 on the Adverse Event Form as adverse events unless they increase in severity 
during the study. 
 
12.1 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 
event, whether listed in the protocol or not, is considered to be 
reportable as a UADE 
 

 
 
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12.3 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).   
All unanticipated adverse device effects (UADE) will be reported as soon as possible, but 
no later than 10 working days after the investigator first learns of the event, to the 
following two entities: 
1. The study sponsor - E-mail the AE CRF to safety@sightsciences.com; and  
2. The reviewing IRB – 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 not later than 5 working days after the sponsor 

 
 
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makes such a determination and not later than 15 working days after the sponsor first 
received notice of the effect. 
13 RISK-BENEFIT ANALYSIS 
13.1 ANTICIPATED CLINICAL BENEFITS 
The TearCare™ System will be performed with the aim of increasing tear break up time 
and improving meibomian gland function.  The anticipated clinical benefit of these 
improvement is relief of the subjects’ dry eye symptoms.  The goal of the procedure is 
to provide a safe, reproducible, and practically feasible alternative to warm compress 
therapy. Additionally, performing the procedure under the direct supervision of a 
trained corneal specialist further ensures the safety and proper delivery of therapy. 
13.2 ANTICIPATED ADVERSE DEVICE EFFECTS 
Anticipated adverse effects associated with the TearCare System have been described 
above in Section 12.2. 
13.3 RESIDUAL RISKS ASSOCIATED WITH THE INVESTIGATIONAL DEVICE, AS 
IDENTIFIED IN THE RISK ANALYSIS REPORT 
Sight Sciences believes that there are no Intolerable residual risks from this fully non-
invasive, controlled heat treatment device that can be easily and quickly removed from 
the patient by the supervising ophthalmologist. 
13.4 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL 
INVESTIGATION 
As with any type of eye procedure, there are potential risks that are associated 
participating in the investigation including: 
 
• Post-procedure Discomfort 
• Blurred Vision 
• Inflammation of eyelids 
In addition, subjects who are asked to discontinue pre-procedure dry eye medications 
may note that their eyes feel more dry.  All anticipated study risks are listed in Section 
12.2. 

 
 
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13.5 POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS 
It is anticipated that there will be no interactions with concomitant medical treatments.   
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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13.7 RISK-TO-BENEFIT RATIONALE 
The risks in this study are low, due to the non-invasive nature of the TearCare System.  
In addition, these risks are generally temporary and are readily treatable or reversible 
with no medical intervention or, in some cases, using standard medical treatment.  
Against these low risks are the potential for a reduction in subjects’ eye discomfort and 
symptoms due to dry eye syndrome.  Reduction in dry eye symptoms holds the 
possibility of several related benefits to the subjects, including: 
 
• Improved vision 
• Improved productivity 
• Reduced dependence on medications and lubricants while simultaneously 
improving physiologic tear production ("your own tears") 
• Reduced costs to subjects to treat their dry eye symptoms 
 
On the basis of this analysis, the potential benefits to subjects related to treatment with 
the TearCare System outweighs the relatively low risk associated with the System. 
14 STATISTICAL CONSIDERATIONS 
14.1 HYPOTHESIS 
This pilot study is not a hypothesis-driven study. 
14.2 SAMPLE SIZE CALCULATION 
Given that this is not a hypothesis-driven study, no sample size was calculated for the 
study.  A sample size of 24 subjects, 12 subjects per arm, was chosen for the study as a 
reasonable number of subjects to obtain an initial evaluation of the safety and 
effectiveness of the TearCare System. 
14.3 PASS/FAIL CRITERIA 
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14.4 STATISTICAL DESIGN, METHOD & ANALYTICAL PROCEDURES TO BE 
USED 
Only basic descriptive statistics will be used to analyze data from the study. 
14.5 INTERIM ANALYSIS AND EARLY TERMINATION CRITERIA 
No interim analysis or early termination criteria are planned for this study. 
14.6 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 
14.7 SUB-GROUP ANALYSES 
Data will be presented according to the following two sub-groups: 
• Treatment with TearCare system 
• Treatment with warm compresses 
14.8 ACCOUNTING FOR ALL DATA 
Groups will be created for ‘intent to treat’ and ‘per-protocol’ enrolled subjects.  
15 MONITORING PROCEDURES 
15.1 MONITORING TO BE CONDUCTED DURING THE INVESTIGATION 
 
• Since Dr. Badawi has already conducted dry-eye related clinical trials with Sight 
Sciences, no site qualification visit will be required. 
• Sight Sciences personnel will meet with the investigator(s) and clinical study 
staff at the time the site begins to enroll in order to ensure that subjects are 
being properly selected and that study data are being correctly recorded. 
• Sight Sciences personnel or designee will visit the clinical site periodically 
during the study to review and/or collect the Case Report Forms.  
• At the conclusion of the trial there will be a study closure visit during which, 
the following items will be reviewed and actions performed: 
o A final inspection of the study binder 
o Accountability and return of all devices and study materials to the 
sponsor 
o Close-out notification to the IRB   

 
 
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15.2 EXTENT OF SOURCE DATA VERIFICATION 
The study CRF will serve as both the source document and the CRF.   
16 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 ever leave the 
site. 
16.1 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.  Sight Sciences will be responsible 
for tracking the receipt of CRFs and data corrections, data entry, and preparing data 
reports for statistical analysis. 
16.2 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 and the FDA notified, 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. 
17 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. 
 
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18 DEVICE FAILURES AND MALFUNCTIONS 
All device failures or malfunctions should be recorded on the Case Report Forms and 
reported to Sight Sciences Customer Service (877-266-1144). 
19 STATEMENTS OF COMPLIANCE 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
B).  The study shall not begin until approval has been obtained from the reviewing IRB.  
The investigator shall conduct this investigation in accordance with the signed 
agreement with the sponsor, the investigational plan, the IDE regulation and other 
applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.  
 
20 STUDY ADMINISTRATION 
20.1 DEVICE ACCOUNTABILITY 
With each shipment of study devices, Sight Sciences will include a Packing List that will 
provide the items shipped. This packing list must be reconciled by the site with the 
contents of the shipment and then the contents of the shipment should be entered on 
the Device Accountability Log (this log is contained within the regulatory binder at the 
site).  All study devices at the site must be stored in a secured/locked area.  Device 
reconciliation activities will also be conducted periodically in conjunction with site 
monitoring visits. 
 
The investigator must maintain accurate records of the receipt of all devices shipped by 
Sight Sciences, including the date and lot numbers received with the use of the device 
inventory tracking log. The use of devices will also be recorded.   
20.2 EARLY TERMINATION OR SUSPENSION OF AN INVESTIGATION 
If the study is terminated, subjects will be followed up in accordance with the normal 
standard of care and adverse events, if any, will be tracked.  No other special 
procedures are necessary. 
 
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. 

 
 
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20.3 INVESTIGATOR RESPONSIBILITIES 
20.3.1 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. 
 
20.3.2 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 or FDA. 
 
20.3.3 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 16.2:  
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. 
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 
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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. 
20.3.4 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. 
 
20.4 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 
Investigator Responsibility Agreement. 

 
 
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21 ASSOCIATED DOCUMENTS 
The investigator should refer to the TearCare Instructions for Use for instructions in how 
to operate the study device. 
22 PUBLICATION POLICY 
Dr. David Badawi, the Principal Investigator, may publish the data in a medical 
newsletter or ophthalmic journal. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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24 APPENDIX A – METHODS FOR OCULAR EXAMS AND TESTS AND 
ADMINISTRATION OF QUESTIONNAIRES 
24.1 EYE EXAM 
A standard eye exam shall be performed, including slit lamp examination to look for the 
presence of erythema, conjunctival discharge, tear meniscus, thickening of the lid 
margins, and telangiectasia. 
24.2 MEIBOMIAN GLAND ASSESSMENT 
Meibomian gland assessment should be performed and the following should be scored: 
 
o Total number of glands from which a fluid secretion can be expressed, regardless 
of qualitative appearance 
o Quality of secretions scored per the scale:35 
o 0 = nothing 
o 1 = toothpaste 
o 2 = cloudy 
o 3 = clear 
 
From this scoring the following endpoints will be assessed: 
• The number of Meibomian glands yielding clear liquid secretions 
• The number of glands secreting any liquid (clear or cloudy) 
• The total Meibomian Gland Score 
24.3 TEAR BREAKUP TIME (TBUT) 
TBUT is an indicator of tear film instability and detects dry eye syndrome due to 
evaporative causes such as meibomian gland disease.  The Dry Eye Test (DET) method 
shall followed using DET test strips (Amcon Laboratories). 
 
To measure TBUT, instill fluorescein into the eye using the DET test strips.  Ask the 
subject to blink several times.  Record the break-up time using a stopwatch.  Repeat the 
test 3 times and take the average of the 3 measurements. 
 
35 Lane SS, DuBiner H, Epstein RJ, et al;  A A New System, the LipiFlow, for the Treatment of Meibomian 
Gland Dysfunction. Cornea. 2012: 31 : 396-404. 

 
 
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24.4 SCHIRMER TEST 
The Schirmer Test measures aqueous tear quantity and is an indication of aqueous-
deficient dry eye.  The Schirmer 1 test, without anesthesia, should be performed by 
placing the filter strip in the inferior fornix for 5 minutes.  Measure wetting in 
millimeters.   
24.5 CORNEAL AND CONJUNCTIVAL STAINING 
Severity of ocular surface disease is assessed with corneal and conjunctival staining.  
Using saline moistened (1%) Lissamine green-impregnated strips, instill the dye on the 
inferior palpebral conjunctiva.   After 15 seconds, perform a slit lamp exam to score the 
corneal and conjunctival staining per the NEI grading system shown below in Figure 1:36 
 
Figure 1:  NEI/Industry Grading System for Corneal and Conjunctival Staining 
 
 
 
 
36 Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J  
995;21: 221–232. 

 
 
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24.6 VISUAL ACUITY 
Best spectacle-corrected visual acuity will be measured using the Snellen method. 
24.7 SPEED QUESTIONNAIRE 
The SPEED Questionnaire will be administered to the subjects in the doctor’s office by 
either the study coordinator or the Investigator.  A total SPEED score is calculated by 
adding the Frequency and Severity scores. 
24.8 OSDI QUESTIONNAIRE 
The OSDI Questionnaire will be administered to the subjects in the doctor’s office by 
either the study coordinator or the Investigator.  The overall OSDI Total score (from 0-
100) and scores for the three subscales will be totaled according to the OSDI 
instructions.  Based on the recommended cutoffs for OSDI Total score, subject results 
are grouped as follows: 
 
o Mild – 13-22 
o Moderate – 23-32 
o Severe – 33 or higher  
24.9 SANDE QUESTIONNAIRE 
The SANDE is a simple dry eye instrument containing two items measuring the 
frequency and severity of symptoms, each was assessed on a 100 mm visual analog 
scale (VAS) ranging from ‘Never/Very comfortable’ to ‘All the time/Very severe’ and 
scored from 0 to 100.   Refer to Figure 2. 
 
A SANDE Total score (also ranging from 0 to 100) is calculated as the square-root of the 
product of the two item scores.  
 
Based on the SANDE total score, subject results are grouped into three categories:  
 
o Mild:  <40 
o Moderate:  40-50 
o Severe:  >50 
 

 
 
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25 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. 
 
 
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 

 
 
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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. 
 
• 
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. 
 

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