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

Sight Sciences

Status

Terminated

Conditions

Dry Eye Syndromes

Treatments

Device: Warm Compress and Lid Massage

Device: TearCare

Study type

Interventional

Funder types

Industry

Identifiers

NCT03502447

05474

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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