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

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: TearCare; Device: Warm Compress and Lid Massage

Detailed Description

This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months.

All subjects will complete an informed consent form indicating their voluntary participation in the study.

Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Florida
    • Miami, Florida, United States, 33176
      • Center for Excellence in Eye Care
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TearCare; TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.	Device: TearCare; TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
Active Comparator: Warm Compress & Lid Massage; Subjects will perform warm compress and lid massage at home daily.	Device: Warm Compress and Lid Massage; Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Tear Break-Up Time From Baseline to Month 1	The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in OSDI Score From Baseline to Month 1	The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.	1 month

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.
• Investigators: Study Director: Jaime Dickerson, PhD, Sight Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 05474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No