SIGHT SCIENCES TearCare Manuale utente

Document Number 07418 Rev C

January 2022

Instructions For Use

TEARCARE.COM

SmartHub INSTRUCTIONS FOR USE

1 INTRODUCTION........................................................ 1

1.1 Contacting Sight Sciences ..................................... 1

2 TEARCARE SYSTEM INFORMATION .................... 1

2.1 Indications for Use................................................... 1

2.2 Contraindications ..................................................... 1

2.3 Warnings .................................................................... 1

2.4 Precautions................................................................2

2.5 Potential Adverse Effects of the Device

on Health....................................................................2

2.6 For Prescription Use only.......................................3

2.7 Clinical Study Summary..........................................3

2.8 Device Description................................................. 12

2.8.1 TearCare SmartHub................................................ 12

2.8.2 TearCare SmartLids................................................ 14

3 PERFORMING A TEARCARE PROCEDURE....... 15

3.1 Unpacking and Checking the

TearCare System Products ................................... 15

3.2 Preparing the Patient ............................................ 15

3.3 Applying the SmartLid ......................................... 16

3.4 Plugging the SmartLids into the SmartHub ..... 17

3.5 Starting a TearCare Procedure ........................... 18

3.6 Adjusting temperature ......................................... 19

3.7 Terminating a procedure early ........................... 20

3.8 Expressing the meibomian glands..................... 20

4 PRODUCT DISPOSAL ........................................... 20

5 CHARGING THE SMARTHUB................................ 21

6 USER MAINTENANCE........................................... 22

6.1 Cleaning the SmartHub........................................ 22

7 TROUBLESHOOTING ............................................ 23

7.1 SmartHub Troubleshooting ................................. 23

7.2 SmartLid Troubleshooting................................... 26

8 SPECIFICATIONS....................................................27

8.1 Thermal Output ......................................................27

8.2 Physical Components ............................................27

8.3 Environmental Conditions ....................................27

8.4 Standards Compliance ......................................... 28

8.4.1 Electromagnetic Emissions ................................. 29

8.4.2 Essential Performance.......................................... 30

8.4.3 EMC Susceptibility ................................................ 30

APPENDIX A: Symbols..................................................... 31

APPENDIX B ...................................................................... 34

Product Returns..................................................... 34

Responsibility of Sight Sciences........................ 34

Adverse Event Reporting .................................... 34

Manufacturer .......................................................... 34

Patents and Trademarks ...................................... 34

Table of Contents

1.1 CONTACTING SIGHT SCIENCES

All questions or concerns about the TearCare® System products

should be directed to:

Sight Sciences, Inc.

4040 Campbell Ave.

Suite 100

Menlo Park, CA 94025

Telephone: (877) 266-1144

Website: www.sightsciences.com

2. TEARCARE SYSTEM INFORMATION

2.1 INDICATIONS FOR USE

The TearCare® System is intended for the application of localized

heat therapy in adult patients with evaporative dry eye disease

due to meibomian gland dysfunction (MGD), when used in

conjunction with manual expression of the meibomian glands.

2.2 CONTRAINDICATIONS

TearCare is contraindicated for patients with the following

conditions. Use of the device in patients with these conditions

may cause serious injury or exacerbation of the condition.

• Recent (i.e. within the last 90 days) surgical procedure to the

eye or eyelid.

• Recent ocular injury.

• History of Herpes Simplex or Herpes Zoster of the eye

oreyelid.

• Active ocular or periocular infection, inﬂammation

orirritation.

• Diminished or abnormal facial, periocular, ocular, or corneal

sensation.

• Ocular surface ulcers.

• Hordeolum, stye, or chalazion.

• Do not use TearCare in patients under the age of 22 years.

• Pacemakers or implantable cardiac deﬁbrillators (ICD).

Useof the TearCare System may aect the performance

ofpacemakers or ICD’s due to electromagnetic interference

(EMI). To avoid any potentially serious safety eects,

patientswith these implants should not be treated with

theTearCareSystem.

• Known allergy to acrylate.

• Known allergy to silicone tissue adhesives.

• Known allergy to copper.

2.3 WARNINGS

• Do not use the TearCare System outside the instructions

for use described in this manual. Doing so can result

inunanticipated patient harm.

• Do not attempt to connect the SmartHub or SmartLid

directly to an electrical outlet of any kind.

• Do not use the TearCare System in or near an MRI suite

ornear a magnetic ﬁeld. Serious injury can occur to a patient

or technician if a TearCare system is brought into an MRI suite.

• The TearCare System has not been tested in the presence

of ﬂammable anesthetics or other ﬂammable agents in

combination with air, nitrous oxide, or oxygen enriched

environments.

• Do not apply SmartLids to non-intact skin (i.e., skin with

active abrasion, cut, burn, rash, inﬂammation, redness, etc.)

1. INTRODUCTION

2.4 PRECAUTIONS

• Use of the TearCare System in patients with eyelid

abnormalities (e.g., entropion, ectropion, tumor, edema,

blepharospasm, lagophthalmos, severe trichiasis, severe ptosis,

etc.) may result in poor adhesion of the SmartLid to the eyelid

and/or reduced beneﬁt.

• Use caution when using the TearCare System in patients with

ocular surface abnormalities (e.g. pterygium, pingueculum,

corneal dystrophies, etc.) as the heat delivered by TearCare

may aggravate these conditions.

• Remove contact lenses from the patient’s eyes prior to use of

TearCare. Patients should wait 60 minutes after the completion

of the TearCare procedure before re-inserting contact lenses.

• Do not apply the SmartLids to any other part of the patient’s

body including the cornea. The SmartLids are only intended

forapplication on the external surface of the patient’s eyelids.

• It is important for patient to keep their eyes open (blinking is

permitted) during treatment, to allow heat to dissipate o of

the ocular surface.

• Eectiveness of the TearCare System has not been established

in subjects for whom the treatment temperature is lowered

from Warmth Level Setting #5 due to patient pain or

discomfort.

• Do not reuse the SmartLids. Cross-contamination can occur

ifre-use is attempted.

• Do not use the TearCare System, its components, or accessories

that appear damaged. Inspect all components for damage

before each use.

• The safety and eectiveness of the TearCare System is not

known in the following patient populations that were excluded

in the OLYMPIA pivotal study: patients under 22 years of age,

dry eye signs and symptoms other than meibomian gland

dysfunction, severe signs and symptoms of dry eye due to

meibomian gland dysfunction (OSDI > 79), mild signs and

symptoms of dry eye due to meibomian gland dysfunction,

andother study exclusions described in Section 2.7 “Clinical

Study Summary.”

2.5 POTENTIAL ADVERSE EFFECTS OF THE DEVICE

ONHEALTH

Below is a list of potential adverse eects that may be associated

with use of the TearCare System. Adverse eects that occurred

in the OLYMPIA pivotal clinical trial are indicated with an asterisk

(*) and additional information regarding these adverse eects is

summarized in Section 2.7 “Clinical Study Summary.”

Potential adverse eects may include but are not limited to:

• Eyelid or eye pain requiring discontinuation of the treatment

procedure

• Eyelid irritation or inﬂammation*

• Ocular surface irritation or inﬂammation*

• Ocular symptoms (such as burning, redness, tearing, visual

disturbance, redness)

• Burning, erythema, or swelling of the eyelids

• Conjunctival infection (moderate or severe)

• Conjunctival abrasion

• Corneal abrasion

• Corneal deformation

• Allergic or inﬂammatory reaction to medical adhesive on the

SmartLid device

• Formation of a chalazion or stye*

2. TEARCARE SYSTEM INFORMATION

• Decline in visual acuity*

• Worsening of dry eye symptoms*

• Increased discomfort or pain of ocular surface (grittiness,

foreign body sensation, etc.)

• Discomfort or pain of eyelids or orbit*

There is a potential risk of thermal injury to eye or eyelid based

onthe device design.

2.6 FOR PRESCRIPTION USE ONLY

Federal (USA) law restricts this device to sale, distribution, or use by

or on the order of a physician. Physician training is required prior to

use of the TearCare System.

2.7 CLINICAL STUDY SUMMARY

A prospective, multicenter, randomized, non-inferiority, masked,

controlled clinical trial (“OLYMPIA”) was performed to demonstrate

the safety and eectiveness of a single TearCare System treatment

compared to a single LipiFlow Thermal Pulsation System to treat

adult patients with Meibomian Gland Dysfunction (MGD).

Study Design

This study was a prospective, randomized, single-masked,

multi-center, non-inferiority, non-signiﬁcant risk device study.

Randomized subjects were followed for one month succeeding

treatment with follow-up data collected at Day 1, Week 2, and

1 Month. A total of 235 subjects (470 eyes) from 10 investigative

centers in the United States participated in the study, comprised

of 169 female and 66 males, ages 22 to 91 years (mean = 55.9 ±

14.4 years). Subjects were randomized 1:1 to receive either a single

TearCare System or LipiFlow System treatment. The TearCare

treatment arm consisted of a 15-minute thermal procedure

followed immediately (i.e., within 3 minutes) by manual expression

of the meibomian glands using the Clearance Assistant. Study

subjects were grouped into two cohorts to account for a SmartLid

design change made during the study. There were 93 subjects

in Cohort 1, comprised of 47 LipiFlow and 46 TearCare subjects

treated with the prior SmartLid design. There were 142 subjects

in Cohort 2, comprised of 73 LipiFlow and 69 TearCare subjects

treated with the current SmartLid design. The eectiveness

endpoints were assessed using data from Cohort 2 and the safety

endpoints were evaluated separately for Cohort 1 and 2. The study

procedures took place between March 2019 and February 2020.

Study Endpoints

The primary eectiveness endpoints included the mean change

from baseline to 1-month in Tear Break-Up Time (TBUT) and

Total Meibomian Gland Secretion Score (MGSS). Secondary

eectiveness endpoints included the mean change from baseline

to 1-month in Ocular Surface Disease Index (OSDI) score, corneal

and conjunctival staining scores, Symptom Assessment in Dry Eye

(SANDE) scores, Eye Dryness Score and meibomian gland health.

The primary safety endpoint was the incidence of ocular adverse

events. The secondary safety endpoints included discomfort/pain

during and after the procedure, change in Best Corrected Visual

Acuity (BCVA), and change in intraocular pressure (IOP).

Description of Study Patients

To participate in the study, subjects were required to be at least

22 years of age with symptoms of dry eye in the past 3 months,

regularly reported use of artiﬁcial tears or lubricants over the

2. TEARCARE SYSTEM INFORMATION

past month to relieve dry eye symptoms, a Tear Break-up Time

(TBUT) of ≤7 seconds in both eyes, an OSDI score of 23-79,

and meibomian gland obstruction in both eyes based on a total

Meibomian Gland Score ≤12 in each eye with at least 15 glands

in each lower eyelid expressible with a sterile cotton swab at the

Baseline visit.

Subjects could not participate in the study if they were using dry

eye medications (such as liﬁtegrast, cyclosporine, antihistamines),

or systemic medications (such as diuretics, anti-hypertensives)

known to cause ocular dryness within speciﬁc timeframes prior

to enrollment, prior dry eye treatments (such as laser, thermal

pulsation, lid debridement, punctal plugs) within speciﬁc

timeframes prior to enrollment, history of eyelid, conjunctiva or

corneal surgery within the past year, use of bimatoprost, Retin

A or isotretinoin, systemic diseases resulting in dry eye (such

as Sjogren’s syndrome, lupus, Grave’s disease). Other exclusion

criteria included history of ocular Herpes Simplex or Herpes Zoster,

any active and clinically signiﬁcant ocular or peri-ocular infection

or inﬂammation or anterior blepharitis or eyelid abnormalities

(such as entropion/ectropion, lagophthalmos) or dermatologic

or cutaneous disease of the eyelid or periocular area or ocular

surface abnormalities that may aect tear ﬁlm distribution or

treatment (such as pterygium, anterior membrane dystrophy) or

conjunctivitis (such as allergic, vernal or giant papillary). Subjects

were also excluded if they had corneal surface abnormalities (such

as corneal epithelial defects, ulcers, dystrophies, keratoconus,

ectatic disease), recurrent clinically signiﬁcant eye inﬂammation

(other than dry eye) or ocular trauma within 3 months prior to

enrollment. Based on the clinical judgement of the investigator,

subjects with meibomian glands having signiﬁcant capping,

atrophy or unable to be expressed were also excluded from

thestudy.

Demographics

The mean age of all 235 enrolled and treated subjects was

55.9 ± 14.4 years. The gender of all randomized subjects was

similar across treatment groups with a combined distribution of

169 (72%) female and 66 (28%) male subjects. The demographic

of all study subjects was similar between the treatment groups.

Asummary of patient demographics is presented in Table 1.

Table 1. Baseline Demographics (Cohort 1 + Cohort 2)

TearCare

(n=115 subjects)

Lipiﬂow

(n=120 subjects)

Combined

(n=235 Subjects)

Age (years)

n 115 120 235

Mean (SD) 57 (14.0) 55 (14.5) 55.9 (14.4)

Median 60 56.5 58.0

Range (min-max) 22 – 91 23 – 86 22 – 91

Gender n(%)

Female 86/115 (74.8%) 83/120 (69.2%) 169/235 (71.9%)

Male 29/115 (25.2%) 37/120 (30.8%) 66/235 (28.1%)

Race, n(%)

American Indian/

Alaska Native

2/115 (1.7%) 0/120 (0.0%) 2/235 (0.9%)

Asian 3/115 (2.6%) 5/120 (4.2%) 8/235 (3.4%)

Black or African

American

4/115 (3.5%) 5/120 (4.2%) 9/235 (3.8%)

TearCare

(n=115 subjects)

Lipiﬂow

(n=120 subjects)

Combined

(n=235 Subjects)

Indian 0/115 (0.0%) 0/120 (0.0%) 0/235 (0.0%)

Iranian 1/115 (0.9%) 0/120 (0.0%) 1/235 (0.4%)

Middle Eastern 0/115 (0.0%) 1/120 (0.8%) 1/235 (0.4%)

Spanish 1/115 (0.9%) 0/120 (0.0%) 1/235 (0.4%)

White 104/115 (90.4%) 109/120 (90.8%) 213/235 (90.2%)

Ethnicity, n(%)

Non-Hispanic

or Latino

94 (82.1%) 101/120 (84.2%) 195/235 (83.1%)

Hispanic or Latino 21 (18.3%) 19/120 (15.8%) 40/235 (17.0%)

Eectiveness Results

The primary eectiveness endpoints were deﬁned as the

change from baseline to 1 month for Tear Break-up Time (TBUT)

and total Meibomian Gland Secretion Score (MGSS) for both

treatment groups in Cohort 2. Subjects in both treatment groups

demonstrated a statistically signiﬁcant improvement in both

endpoints and the TearCare arm of the study established

non-inferiority relative to the LipiFlow arm for both TBUT

andMGSS. Results are listed in Tables 2 and 3 below.

Table 2. Change in TBUT at 1 month compared to baseline

(Cohort 2)

Visit Parameter Statistics TearCare LipiFlow

Baseline

N (eyes) 134 136

TBUT

mean(sd) 4.62 (1.19) 4.49 (1.05)

median 4.65 4.36

min, max [1.12, 6.85] [0.87, 6.92]

95% CI [4.41, 4.82] [4.32, 4.67]

Month 1

N (eyes) 134 136

TBUT

mean(sd) 7.64 (4.64) 7.08 (3.19)

median 6.59 6.39

min, max [2.81, 32.50] [2.94, 23.83]

95% CI [6.84, 8.43] [6.54, 7.62]

TBUT change-from-

baseline

mean(sd) 3.02 (4.41) 2.58 (3.28)

median 1.95 1.90

min, max [-2.39, 28.00] [-1.75, 20.79]

95% CI [2.27, 3.78] [2.03, 3.14]

2. TEARCARE SYSTEM INFORMATION

Table 3. Change in MGSS at 1 month compared to baseline (Cohort 2)

Visit Parameter Statistics TearCare LipiFlow

Baseline

N (eyes) 134 136

Total Meibomian Gland

Secretion Score

mean(sd) 6.54 (3.11) 6.29 (2.75)

median 7.00 6.00

min, max [0.00, 12.00] [0.00, 12.00]

95% CI [6.01, 7.07] [5.83, 6.76]

Month 1

N (eyes) 134 136

Total Meibomian Gland

Secretion Score

mean(sd) 17.74 (11.63) 17.38 (11.08)

median 16.00 16.00

min, max [0.00, 45.00] [0.00, 41.00]

95% CI [15.75, 19.73] [15.50, 19.26]

Total Meibomian Gland

Secretion Score change-

from-baseline

mean(sd) 11.20 (11.13) 11.09 (10.41)

median 8.00 8.00

min, max [-8.00, 45.00] [-8.00, 36.00]

95% CI [9.30, 13.10] [9.32, 12.85]

Results of the secondary endpoints for both treatment groups

inCohort 2 are presented in the following tables:

Table 4. OSDI – Mean change from baseline at 1-Month (Cohort 2)

Parameter TearCare LipiFlow

N (subjects) 67 68

Baseline (sd) 52.0 ± 14.4 51.1 ± 16.1

1-Month

change (sd)

min, max

24.2 ± 17.7

-27.88 ± 20.5

-66.7, 35.0

27.7 ± 19.6

-23.4 ± 17.7

-59.1, 30.2

Table 5. Change in Total Corneal Staining at 1 month compared

tobaseline (Cohort 2)

Visit Parameter Statistics TearCare LipiFlow

Baseline

N (eyes) 134 136

Total Corneal

StainingScore

mean(sd) 2.51 (2.09) 2.51 (2.31)

median 2.00 2.00

min, max [0.00, 9.00] [0.00, 9.00]

Indice

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