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

NCT03502447 | Terminated Results FDA Device

• 1 other identifier: 05474
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Change in OSDI Score From Baseline to Month 1

  1 month

Study Arms (2)

TearCare

EXPERIMENTAL

TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.

Device: TearCare

Warm Compress & Lid Massage

ACTIVE COMPARATOR

Subjects will perform warm compress and lid massage at home daily.

Device: Warm Compress and Lid Massage

Interventions

TearCare DEVICE

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.

TearCare

Warm Compress and Lid Massage DEVICE

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.

Warm Compress & Lid Massage

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (6)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: VP Medical & Clinical Affairs
• Organization: Sight Sciences, Inc.

info@sightsciences.com

877-266-1144

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 18, 2018
• Study Start: April 20, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)