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Meibomian Gland Dysfunction (Disorder)XTENDNCT07365735

TearCare MGX™ System With and Without Warming Hold

A study testing localized heat therapy in people with Meibomian Gland Dysfunction (Disorder), run by Sight Sciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Meibomian Gland Dysfunction (Disorder)
What is being tested?
localized heat therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
17 Mar 2026to 19 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
  • Contact lens use within 2 weeks of the Procedure visit. Subjects presenting at the Screening visit using contact lenses must agree to discontinue use for a full 2 weeks (14 days) prior to the Procedure visit.
  • Active hordeolum, stye, or chalazion at the time of the Screening visit.
  • History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
  • Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation.
  • Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to Screening.
  • 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 cotton swab.
  • 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 Screening.
  • Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
  • Systemic diseases, in the Investigator's medical judgement, 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 /Retin A derivatives.
  • Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
  • Subject is currently using Latisse, Lash Boost or any other type of eyelash growth serum. Prostaglandin analog products such as Latisse should not be used within 30 days of the Screening visit.
  • Temporary false eyelashes, lash extensions, or any other type of false eyelash within 15 days of the Screening Visit.
  • Allergies to silicone tissue adhesives, acrylates and/or copper.
  • Subject has a pacemaker or implantable cardiac defibrillators (ICD).
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Eye Clinic

    Brecksville, Ohio, 44141

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled Trial of the TearCare MGX™ System With and Without Warming Hold (Xtend)

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).

Read the detailed description

This study will collect data to assess the clinical utility of the Warming Hold period. The TearCare MGX Warming hold is a 10-minute period beyond completion of the Core Therapy time that serves to preserve elevated temperature by outputting only enough energy to maintain heat at the lowest setting of the system. At the minimum warmth setting the SmartLid device surfaces provide a steady state temperature of 39.0°C.

This is a prospective, randomized, assessor-masked, single-center, non-significant risk (NSR) study. To reduce potential bias in the study, study staff performing the endpoint assessments will be masked. Subjects will also be masked as to group assignment.

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).

TearCare procedures in this study will include an in-office eyelid debridement, 15-minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects will receive one in-office TearCare procedure at the Procedure Visit.

Being tested
localized heat therapy
Keywords
TearCare, XTEND, Meibomian Gland Dysfunction, MGD
Medical subject headings
Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • localized heat therapyDevice

    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.

Study groups in NCT07365735
Study groupRoleWhat they receive
TearCare MGX with Warming HoldActive comparator15 minute thermal treatment with TearCare MGX followed by 10 minute warming hold
Receives: Device: localized heat therapy
TearCare MGX without Warming HoldActive comparator15 minute thermal treatment with TearCare MGX without subsequent warming hold period
Receives: Device: localized heat therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Mean change from Screening visit baseline in 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 change from baseline in the MGSS is the score obtained following treatment at the procedure visit minus the score obtained for the same eye at the Screening visit. The mean is the arithmetic mean of this difference for all eyes.

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

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

    The Meibomian glands yielding any liquid (MGYAL) is the number of glands in the lower eyelid secreting any liquid, (regardless of graded quality). The score can range from 0 (no glands secreting liquid), to 15 (all 15 glands with liquid secreted). A higher score is better. The mean change from Screening visit baseline is the mean difference between the MGYAL at screening and the MGYAL post-procedure at the procedure visit.

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

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

    The Meibomian glands yielding clear liquid (MGYCL) is the number of glands in the lower eyelid secreting clear liquid. The score can range from 0 (no glands secreting clear liquid), to 15 (all 15 glands with clear liquid secreted). A higher score is better. The mean change from Screening visit baseline is the mean difference between the MGYCL at screening and the MGYCL post-procedure at the procedure visit.

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

  4. Subject Comfort during expression of second lid

    Subject Comfort during expression of second lid is assessed following treatment using a subject completed Likert scale rating the relative comfort of eyelid gland expression for the first lid expressed versus the second.

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

  5. Ease of expression

    Ease of expression is assessed following treatment using a masked-assessor completed Likert scale rating the relative ease of eyelid gland expression for the first lid expressed versus the second.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start17 Mar 2026
  3. Primary completion19 May 2026
  4. Study completion19 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365735
Sponsor's protocol ID
CLN1 10280
Acronym
XTEND
Status last verified
Jun 2026
First submitted
22 Jan 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Protection of patient confidentiality.

Questions about this trial

What is this clinical trial studying?

A study testing localized heat therapy in people with Meibomian Gland Dysfunction (Disorder), run by Sight Sciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference between eyes in Meibomian Gland Secretion Score (MGSS) (time frame: MGSS used to calculate the difference in MGSS between eyes is obtained post-treatment at the procedure visit (Day 0).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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