- Prospective, Multi-Center, Randomized, Masked, Post-Market
- Sample size: 135 subjects
- 10 Centers
- 1 Month Follow-up
Objective
Current Stage
Overview
- 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.
- 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
- Mean Change from baseline to 1 month in:
- Safety
- Device-related Adverse Events
- Discomfort/pain during treatment
- Change in best corrected visual acuity (ETDRS)
- Change in intraocular pressure (IOP)
- 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)