TearCare System to Treat Dry Eye Disease

NCT ID: NCT03857919

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-03
• Study Completion Date: 2020-12-18

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.

Detailed Description

The primary objective of this study was to demonstrate the safety and effectiveness of a single TearCare System treatment compared to a single LipiFlow treatment in relieving the signs and symptoms of dry eye disease. This study was conducted to collect data to support a modification to the TearCare indication for use to read as follows, "The TearCare® System is indicated for the treatment of the signs and symptoms of dry eye disease (DED)."

Conditions

Dry Eye; Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TearCare

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

Group Type: EXPERIMENTAL

TearCare

Intervention Type: 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.

LipiFlow

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

Group Type: ACTIVE_COMPARATOR

LipiFlow

Intervention Type: 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.

Interventions

TearCare

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.

Intervention Type: DEVICE

LipiFlow

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.

Intervention Type: DEVICE

Other Intervention Names

Thermal Pulsation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Use of any of the following medications:

1. Restasis or Xiidra within 60 days prior to enrollment;

2. Antihistamines (oral or topical) within 10 days prior to enrollment;

3. 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;

4. Accutane (at any time);

5. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or

6. 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:

1. Office-based dry eye treatment (e.g. IPL, thermal pulsation [Lipiflow], etc.) within 12 months prior to enrollment;

2. Meibomian gland expression within 6 months prior to enrollment;

3. Blephex or debridement within 3 months prior to enrollment is an exclusion;

4. Punctal occlusion or punctal plug placement within 30 days prior to enrollment;

5. Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or

6. 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.
• Contact lens use within the past 2 weeks. (Subjects must refrain from wearing contact lenses during the 1-month follow-up.)
• History of Ocular Herpes Simplex or Ocular Herpes Zoster
• Any active, clinically significant ocular or peri-ocular infection or inflammation
• Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
• Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
• Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
• Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
• In the clinical judgement of the investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton swab.
• Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, Salzmann's nodules, etc.)
• Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
• Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis.
• Ocular trauma within 3 months prior to enrollment.
• Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
• Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
• Subject is currently using Retin A or Latisse.
• Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
• Subject is currently using Lash Boost.
• Allergies to silicone tissue adhesives
• Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study.
• Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol. For example, subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime Dickerson, PhD

Role: STUDY_DIRECTOR

Sight Sciences

Locations

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Harvard Eye Associates

Laguna Hills, California, United States

Eye Research Foundation

Newport Beach, California, United States

Loh Ophthalmology Associates

Miami, Florida, United States

Jackson Eye

Lake Villa, Illinois, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

Ophthalmology Associates

St Louis, Missouri, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Parkhurst NuVision

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36065356 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

06196

Identifier Type: -

Identifier Source: org_study_id