A Pilot Study of the TearCare System in Adults With Dry Eye Disease

NCT03006978 | Completed Results FDA Device

• 1 other identifier: 05429
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a small, pilot study intended to determine the feasibility of this product.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean Change in Tear Breakup 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. An increase in TBUT represents an improvement.

  4 weeks

Secondary Outcomes (4)

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

  1 month

• Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline

  1 Month

• Mean Change in OSDI Score From Baseline to Month 1

  1 Month

• Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1

  1 Month

Study Arms (2)

TearCare

EXPERIMENTAL

Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands. This procedure will be performed at the Baseline visit.

Device: TearCare

Warm Compress

ACTIVE COMPARATOR

Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.

Device: Warm Compress

Interventions

TearCare DEVICE

TearCare

Warm Compress DEVICE

Warm Compress

Eligibility Criteria

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

You may qualify if:

• At Least 18 Years of age
• Reports dry eye symptoms within 3 months of the screening exam with a SPEED score \>=6
• Schirmer 1 value of \<10 mm in at least one eye or a Tear Breakup time \<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, Ltd.

Arlington Heights, Illinois, 60005, United States

Location

Related Publications (1)

• Badawi D. A novel system, TearCare(R), for the treatment of the signs and symptoms of dry eye disease. Clin Ophthalmol. 2018 Apr 10;12:683-694. doi: 10.2147/OPTH.S160403. eCollection 2018.

  PMID: 29692600 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jaime Dickerson
• Organization: Sight Sciences

jdickerson@sightsciences.com

(877) 266-1144

Study Officials

• David Badawi, MD

  Sight Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)