Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease

Stopped early · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage. NOTE: All sites have been selected for this study.

Key facts

Study ID

NCT03502447

Run by

Sight Sciences, Inc.

People needed

14

Starts

2018-04-20

Expected to finish

2018-12-04

Last updated by the study team

2025-09-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Harvard Eye Associates — Laguna Hills, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Center for Excellence in Eye Care — Miami, Florida, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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