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

Status:	Terminated
Conditions:	Ocular, Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	22 - Any
Updated:	3/2/2019
Start Date:	April 20, 2018
End Date:	January 2, 2019

Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease

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.

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

We found this trial at

sites

Vance Thompson Vision

Sioux Falls, South Dakota 57105

Phone: 604-371-7064

from

Sioux Falls, SD