Study of the TearCare System in Dry Eye Disease
Purpose
This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease. NOTE: All sites have been selected for this study.
Condition
- Dry Eye
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosed with dry eye disease - Signs and symptoms of dry eye disease - Best corrected visual acuity 20/100 or better - Willing and able to comply with study procedures - Willing and able to provide consent
Exclusion Criteria
- Active ocular infection or inflammation - History of eyelid, conjunctiva or corneal surgery within the past year. - Recent office-based dry eye treatment, punctal occlusion or punctal plug placement - Contact lens wearer - Significant ocular surface or eyelid abnormalities, recent ocular trauma - Certain corneal surface abnormalities - Use of medications for treatment of dry eye or medications that cause dry eye - Systemic disease that results in dry eye
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TearCare |
All subjects in the study will undergo the TearCare procedure one time at the baseline visit. They will then be followed out to one month. |
|
Recruiting Locations
Eye Research Institute
Newport Beach, California 92663
Newport Beach, California 92663
More Details
- NCT ID
- NCT03588624
- Status
- Recruiting
- Sponsor
- Sight Sciences, Inc.