TearCare System to Treat Dry Eye Disease

NCT03857919 | Completed Results FDA Device

• 1 other identifier: 06196
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• Change in Tear Break-Up Time (TBUT) From Baseline

  Tear Break-Up Time is the time measured to the first observation of a break in the tear film

  1 month

• Change in Meibomian Gland Secretion Score From Baseline

  The Meibomian Gland Secretion Score grades the consistency of secretions from the meibomian glands. Fifteen meibomian glands in each of the lower eyelids were gently pressed and the secretions were scored on the scale below. Sum of the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45. A higher number indicates more normal meibomian gland activity. Score Description of Secretion: 0 - Nothing 1. \- Toothpaste 2. \- Cloudy 3. \- Clear

  1 month

Secondary Outcomes (7)

• Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline

  1 month

• Change in Corneal Staining Score From Baseline

  1 month

• Change in Conjunctival Staining Score From Baseline

  1 month

• Change in Symptom Assessment in Dry Eye (SANDE) Scores From Baseline

  1 month

• Change in Eye Dryness Score (EDS) From Baseline

  1 month

Study Arms (2)

TearCare

EXPERIMENTAL

Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.

Device: TearCare

LipiFlow

ACTIVE COMPARATOR

Subjects will have heat and pressure applied to the eyelids for 12 minutes.

Device: LipiFlow

Interventions

TearCare DEVICE

The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.

TearCare

LipiFlow DEVICE

The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.

Also known as: Thermal Pulsation

LipiFlow

Eligibility Criteria

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

You may qualify if:

• At least 22 years of age
• Reports dry eye symptoms within the past 3 months
• Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
• OSDI Score of 23-79
• 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.
• At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
• Best corrected visual acuity of 20/100 or better in both eyes.
• Willing and able to comply with the study procedures and follow-up
• Willing and able to provide informed consent
• English-speaking

You may not qualify if:

• Use of any of the following medications:
• Restasis or Xiidra within 60 days prior to enrollment;
• Antihistamines (oral or topical) within 10 days prior to enrollment;
• Systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
• Accutane (at any time);
• Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
• Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment.
• NOTE: Use of any of the above medications (with the exception of 1c) is not permitted during the 1 month follow-up period.
• Any of the following dry eye treatments:
• Office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment;
• Meibomian gland expression within 6 months prior to enrollment;
• Punctal occlusion or punctal plug placement within 30 days prior to enrollment;
• Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or
• Any history of meibomian gland probing
• History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (10)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Loh Ophthalmology Associates

Miami, Florida, 33143, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Holland EJ, Loh J, Bloomenstein M, Thompson V, Wirta D, Dhamdhere K. A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease. Clin Ophthalmol. 2022 Aug 30;16:2861-2871. doi: 10.2147/OPTH.S368319. eCollection 2022.

  PMID: 36065356 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Results Point of Contact

• Title: Tommie Rodriguez, Senior Clinical Research Manager
• Organization: Sight Sciences

trodriguez@sightsciences.com

18186873310

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: February 26, 2019
• First Posted: February 28, 2019
• Study Start: March 3, 2019
• Primary Completion: February 17, 2020
• Study Completion: December 18, 2020
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)