TearCare System to Treat Dry Eye Disease

Description

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System 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. NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.

Conditions

Dry Eye, Meibomian Gland Dysfunction

Talk to us

Study Overview

On this page

Study Details

Study overview

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System 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. NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.

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

TearCare System to Treat Dry Eye Disease

Condition
Dry Eye
Intervention / Treatment

-

Contacts and Locations

Miami

Center for Excellence in Eye Care, Miami, Florida, United States, 33176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * At least 22
  • * Subject has dry eye symptoms and uses artificial tears/lubricants regularly
  • * Subject has moderate to severe symptoms based on a dry eye questionnaire
  • * Subject has an abnormal tear break-up time
  • * Subject's eyelid glands secrete a low amount of meibum
  • * Best corrected visual acuity 20/100 or better
  • * Willing and able to comply with protocol
  • * Willing and able to provide consent
  • * English-speaking
  • * Use of medications that treat dry eye disease or that are known to cause ocular dryness.
  • * Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
  • * Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
  • * History of eyelid, conjunctival or corneal surgery within the past year.
  • * Contact lens use within past 2 weeks
  • * Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sight Sciences, Inc.,

Study Record Dates

2019-10