Pilot Study of TearCare System - Long-Term Extension

NCT03804502 | Completed Results FDA Device

• 1 other identifier: 06215
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Mean Change in Tear Break-Up Time From Extension Study 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 resulting in a single TBUT value for each subject (n=12).

  1 month

Secondary Outcomes (6)

• Mean Change in Meibomian Gland Score From Extension Study Baseline to Month 1

  1 month

• Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1

  1 month

• Mean Change in OSDI Questionnaire Result From Extension Study Baseline to Month 1.

  1 month

• Mean Change in Corneal Staining From Extension Study Baseline to Month 1

  1 month

• Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1

  1 month

Study Arms (1)

TearCare

EXPERIMENTAL

Subjects will receive one TearCare treatment at the baseline visit

Device: TearCare

Interventions

TearCare DEVICE

The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.

TearCare

Eligibility Criteria

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

You may qualify if:

• Previously enrolled in the TearCare arm of the TearCare Pilot Study
• Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
• TBUT of \<10 seconds in at least one eye
• Willing to comply with the study, procedures, and follow-up
• Willing and able to provide consent

You may not qualify if:

• Any active ocular or peri-ocular infection or inflammation
• Recurrent eye inflammation within the past 3 months
• Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
• Ocular surface abnormalities that may affect tear film distribution or treatment
• Abnormal eyelid function in either eye
• Diminished or abnormal facial, periocular, ocular or corneal sensation
• Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
• Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
• Allergies to silicone tissue adhesives
• An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
• Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
• Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
• Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
• Participation in another ophthalmic clinical trial within the past 30 days
• Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (1)

Central Eye Care

Arlington Heights, Illinois, 60005, 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, Inc.

jdickerson@sightsciences.com

1-877-266-1144

Study Officials

• David Badawi, MD

  Sight Sciences, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 11, 2019
• First Posted: January 15, 2019
• Study Start: December 17, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)