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

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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.

CONTRAINDICATIONS

^®

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 the TearCare® System in patients under the age of 22 years.
Pacemakers or implantable cardiac defibrillators (ICD). Use of the TearCare® System may affect the performance of pacemakers or ICD’s due to electromagnetic interference (EMI). To avoid any potentially serious safety effects, 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.

WARNINGS

Do not use the TearCare^® System outside the instructions for use. 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.)

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.
It is important for patient to keep their eyes open (blinking is permitted) during treatment, to allow heat to dissipate off of the ocular surface.
Effectiveness 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 a TearCare^® System, its components, or accessories that appear damaged. Inspect all components for damage before each use.
The safety and effectiveness 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 the TearCare^®Instructions for Use.

POTENTIAL ADVERSE EVENTS

Potential adverse events 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)
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*
There is a potential risk of thermal injury to eye or eyelid based on the device design.