TearCare MGX™ System With and Without Warming Hold

NCT07365735 | Active Not Recruiting FDA Device

• 1 other identifier: CLN1 10280
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

TearCare is an office-based thermal therapeutic eyelid technology cleared by the US Food and Drug Administration for the treatment of evaporative dry eye disease due to meibomian gland dysfunction. In this randomized study, TearCare procedures using the TearCare MGX System (study device) with the extended Warming hold feature will be compared with TearCare procedures using the TearCare MGX System without the Warming hold (control group).

Conditions

Meibomian Gland Dysfunction (Disorder)

Keywords

TearCare; XTEND; Meibomian Gland Dysfunction; MGD

Outcome Measures

Primary Outcomes (1)

• Mean difference between eyes in Meibomian Gland Secretion Score (MGSS)

  The Meibomian Gland Secretion Score (MGSS) 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 The difference between eyes in the MGSS is the score for the right eye minus the score for the left eye. The mean is the arithmetic mean of this difference for all subjects.

  MGSS used to calculate the difference in MGSS between eyes is obtained post-treatment at the procedure visit (Day 0).

Secondary Outcomes (5)

• Mean change from Screening visit baseline in MGSS

  MGSS is assessed at the Screening visit (Day -30 to Day -7) and at the Procedure visit (Day 0)

• Mean change from Screening visit baseline in Meibomian Glands Yielding Any Liquid (MGYAL)

  MGYAL is assessed at the Screening visit (Day -30 to -7) and at the Procedure visit (Day 0)

• Mean change from Screening visit baseline in Meibomian Glands Yielding Clear Liquid (MGYCL)

  MGYCL is assessed at the Screening visit (Day -30 to Day -7) and post-treatment at the Procedure visit (Day 0)

• Subject Comfort during expression of second lid

  Subject Comfort during expression of second lid is assessed post-treatment at the Procedure visit (Day 0)

• Ease of expression

  Ease of expression is assessed following treatment at the Procedure visit (Day 0)

Study Arms (2)

TearCare MGX with Warming Hold

ACTIVE COMPARATOR

15 minute thermal treatment with TearCare MGX followed by 10 minute warming hold

Device: localized heat therapy

TearCare MGX without Warming Hold

ACTIVE COMPARATOR

15 minute thermal treatment with TearCare MGX without subsequent warming hold period

Device: localized heat therapy

Interventions

localized heat therapy DEVICE

Blink-assisted, open eye therapy. Heat (45 degrees C) applied for 15 minutes to the upper and lower eyelids, followed by manual expression of the meibomian glands.

TearCare MGX with Warming Hold; TearCare MGX without Warming Hold

Eligibility Criteria

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

You may qualify if:

• Male or female subjects, 22 years of age or older
• Reports dry eye symptoms within the past 6 months
• OSDI score of 23 to 79
• 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, OU.
• Willing and able to comply with the study procedures and follow-up
• Understands and signs the informed consent.

You may not qualify if:

• Use of:
• Cyclosporine, Xiidra, or serum tears within 60 days prior to Screening;
• Antihistamines (oral or topical) within 7 days prior to Screening;
• Oral tetracyclines or azithromycin within 30 days prior to Screening;
• Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to Screening
• Isotretinoin (e.g. Accutane) at any time.
• Any of the following dry eye treatments:
• Office-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \[LipiFlow\], iLux etc.) within 12 months prior to Screening either as part of routine care or clinical investigation;
• Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);
• Meibomian gland expression within 6 months prior to Screening;
• Blephex or debridement within 3 months prior to Screening;
• Punctal occlusion (including collagen, e.g. Soft Plug, UltraPlug, or crosslinked hyaluronic acid, e.g. Lacrifill) or punctal plugs within 15 days of the Screening visit;
• Use of tear neurostimulators (i.e., True Tear, iTear100, Tyrvaya) within 2 weeks of the baseline visit. (Subjects must refrain from using tear neurostimulators for the duration of the study);
• Any history of meibomian gland probing.
• History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (1)

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Thomas Chester, OD

  Cleveland Eye Clinic

  PRINCIPAL INVESTIGATOR

• Jaime Dickerson, PhD

  Sight Sciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 26, 2026
• Study Start: March 17, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)