OLYMPIA
TearCare System Clinical Study

Objective

To show the dominance of TearCare System in the market.

Current Stage

Closed

Overview

Design

Prospective, Multi-Center, Randomized, Masked, Post-Market
Sample size: 135 subjects
10 Centers
1 Month Follow-up

Criteria

Reports dry eye symptoms within the past 3 months
Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
OSDI Score of 23‐79
TBUT of ≤7 seconds in both eyes
Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.

Endpoint

Effectiveness:
- Mean Change from baseline to 1 month in:
  - Tear Break‐Up Time (TBUT)
  - Total Meibomian Gland Secretion Score (MGSS)
- Mean Change from baseline to 1 month in:
  - Ocular Surface Disease Index (OSDI) score
  - Corneal staining scores
  - Conjunctival staining scores
  - Symptom Assessment in Dry Eye (SANDE) scores
  - Eye Dryness Score
  - Number of Meibomian Glands Yielding any liquid
  - Number of Meibomian Glands Yielding clear liquid
Safety
- Device-related Adverse Events
- Discomfort/pain during treatment
- Change in best corrected visual acuity (ETDRS)
- Change in intraocular pressure (IOP)

Details

Study success: Change in TBUT and MGSS at 1 month after TearCare treatment is non-inferior to LipiFlow treatment
Cohort 1: Initial SmartLid design
Cohort 2: Modified SmartLid design
Sample size: 235 total subjects treated
- 100 in cohort 1 (Safety analysis only)
- 135 in Cohort 2 (Effectiveness and Safety analysis)

Purpose

This study is to demonstrate the safety and effectiveness of a single TearCare® treatment compared to a single LipiFlow treatment to treat the signs and symptoms of dry eye disease in adult patients. This objective will be met by demonstrating non‐inferiority of the TearCare treatment for each of the primary effectiveness endpoints.

Study ID: ClinicalTrials.gov Identifier NCT03861169

Contact Info: kdhamdhere@sightsciences.com

Close

Indications and Safety Information

Indications for Use

The TearCare® System is indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.

CONTRAINDICATIONS

The TearCare System is contraindicated for patients with:
Recent (i.e. within the last 90 days) intraocular or periocular surgery.
Recent ocular injury.
Recent history of Ocular Herpes Simplex or Herpes Zoster.
Active ocular or periocular infection or inflammation.
Diminished or abnormal facial, periocular, ocular, or corneal sensation.
Ocular surface ulcers
Do not use the TearCare System in patients under the age of 22 years.

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 use the TearCare System in patients with a known allergy to silicone tissue adhesives.
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.

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 the System may aggravate these conditions.
Remove contact lenses from the patient’s eyes prior to use of the TearCare System. 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.
Do not reuse the SmartLids. Cross-contamination can occur if re-use is attempted.
Do not use a TearCare System, its components, or accessories that appear damaged. Inspect all components for damage before each use.

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with the use of the TearCare System include the following:

Burn, 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
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

Federal (U.S.A.) law restricts the TearCare System to the sale, distribution, or use by, or on the order of a licensed medical practitioner.

The TearCare® System is commercially available in the United States.

TearCare®, SmartLids®, and SmartHub® are registered trademarks of Sight Sciences. Clearance Assistant™ is a trademark of Sight Sciences and for use only by Sight Sciences.