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