Study of the TearCare System in Dry Eye Disease

NCT03588624 | Completed Results FDA Device

• 1 other identifier: 06001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

This study was conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline

  TBUT is an indicator of tear film instability and measures the length of time it takes for the tear film to break down. An increase in TBUT represents an improvement.

  1 month

Secondary Outcomes (4)

• Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Month 1

  1 month

• Total Meibomian Gland Secretion Score at 1 Month

  1 month

• Corneal Staining Score at1 Month

  1 month

• Conjunctival Staining Score at 1 Month

  1 Month

Study Arms (1)

TearCare

EXPERIMENTAL

All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.

Device: TearCare

Interventions

TearCare DEVICE

The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.

TearCare

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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
• TBUT of ≤7 seconds in both eyes
• Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye.
• At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
• Best spectacle 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:

• 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
• 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.
• 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.
• Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.)
• Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.)
• History of Ocular Herpes Simplex or Ocular Herpes Zoster
• Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.)
• Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, distichiasis, trichiasis)
• Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
• Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area
• Ocular trauma within 3 months prior to enrollment
• Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis
• Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
• Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (3)

Eye Research Institute

Newport Beach, California, 92663, United States

Location

Arlington Eye Physicians

Arlington Heights, Illinois, 60005, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: VP Medical and Clinical Affairs
• Organization: Sight Sciences

info@sightsciences.com

(877) 266-1144

Study Officials

• Jaime C Dickerson, PhD

  Sight Sciences

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 17, 2018
• Study Start: July 12, 2018
• Primary Completion: October 11, 2018
• Study Completion: November 8, 2018
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)