TearCare for Meibomian Gland Dysfunction

(XTEND Trial)

Overseen By Erin Kreidler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sight Sciences, Inc.

Must not be taking: Cyclosporine, Antihistamines, Isotretinoin, others

Disqualifiers: Eye surgery, Contact lenses, Herpes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two different uses of the TearCare MGX System, a device designed to treat evaporative dry eye caused by meibomian gland dysfunction, where the glands in the eyelids become blocked. The study will test whether adding a warming hold after the treatment makes a difference. Individuals who have experienced dry eye symptoms in the last six months and have issues with their meibomian glands might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for dry eye relief.

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications before joining. You must not have used cyclosporine, Xiidra, or serum tears within 60 days, antihistamines within 7 days, oral tetracyclines or azithromycin within 30 days, and certain eye medications like antibiotics or steroids within 30 days before the screening.

What prior data suggests that the TearCare MGX System is safe for treating meibomian gland dysfunction?

Research has shown that the TearCare MGX System is generally safe for treating dry eye disease caused by meibomian gland issues. Studies indicate that the TearCare procedure, which warms the eyelids, improves symptoms without major safety concerns. One study found that a single 15-minute treatment effectively relieved dry eye symptoms. Another study confirmed TearCare's safety and effectiveness for treating these symptoms. Although the FDA has approved the system for this use, its safety when combined with other treatments remains unestablished. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Meibomian Gland Dysfunction (MGD), like warm compresses and eyelid massages, focus on improving oil gland function through external heat application. However, the TearCare MGX System stands out by delivering a targeted 15-minute thermal treatment directly to the eyelids, followed by an optional warming hold. This approach allows for a more controlled and consistent heat application, which could potentially enhance the effectiveness of the treatment. Researchers are particularly excited about this system because it may offer more precise and reliable results, improving symptoms more effectively than traditional methods.

What evidence suggests that the TearCare MGX System is effective for meibomian gland dysfunction?

Research has shown that the TearCare MGX System effectively treats dry eye caused by meibomian gland issues. In this trial, participants will receive either a 15-minute thermal treatment with TearCare MGX followed by a 10-minute warming hold or a 15-minute thermal treatment without the warming hold. One study found that a single 15-minute session significantly improved symptoms, as measured by the SPEED score, which tracks dry eye symptoms. Another study found that TearCare helped the eyes stay moist longer and reduced eye damage by improving tear breakup time and reducing corneal staining. These improvements suggest that the TearCare MGX System enhances meibomian gland function, providing relief from dry eye symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Thomas Chester, OD

Principal Investigator

Cleveland Eye Clinic

Jaime Dickerson, PhD

Principal Investigator

Sight Sciences, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with dry eye disease caused by Meibomian Gland Dysfunction or Blepharitis. Participants should be suitable for office-based thermal eyelid treatment. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions and factors relevant to the study.

Inclusion Criteria

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

My eyes have blocked oil glands with a low secretion score.

Exclusion Criteria

I haven't used Cyclosporine, Xiidra, or serum tears in the last 60 days.

I haven't used any eye drops for infection, glaucoma, swelling, or pain in the last 30 days.

History of Herpes Simplex or Herpes Zoster of the eye or eyelid

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks

1 visit (in-person)

Treatment

Participants receive a 15-minute bilateral thermal session with the TearCare System, followed by manual expression of the meibomian glands

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in Meibomian Gland Secretion Score (MGSS) and other secondary outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TearCare MGX System

Trial Overview

The study tests the effectiveness of a device called TearCare MGX System in treating dry eye disease. It compares two methods: one using an extended warming feature (study group) versus standard use without this feature (control group).

How Is the Trial Designed?

Group I: TearCare MGX with Warming Hold Active Control 1 Intervention

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

Group II: TearCare MGX without Warming Hold Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Sight Sciences, Inc.

Lead Sponsor

Trials

14

Recruited

1,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07365735

Study Details | NCT07365735 | A Prospective, ...

TearCare procedures in this study will include an in-office eyelid debridement, 15-minute bilateral thermal session with the TearCare System, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12559067/

Long-term efficacy of three treatments for severe MGD - PMC

MGX demonstrated favorable short-term outcomes, especially in NIBUT and corneal fluorescein staining (CFS), likely reflecting efficient ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K231084.pdf

Sight Sciences, Inc. Rachel M. Franco Sr. Regulatory Affairs ...

Safety and effectiveness of the TearCare MGX System has not been established when used in conjunction with any other meibomian gland expressor.

4.

openophthalmologyjournal.com

openophthalmologyjournal.com/VOLUME/17/ELOCATOR/e187436412308280/FULLTEXT/

MGrx - A Novel Multi-modal Thermal Device for Treating ...

A single 15-minute MGrx treatment was effective at significantly improving dry eye symptoms secondary to MGD in adult patients, as measured by SPEED score.

5.

va.gov

va.gov/COMMUNITYCARE/docs/providers/CDI/IVC-CDI-00011.pdf

Thermal Evacuation and Intense Pulsed Light Therapy for ...

The study included 20 patients and used the meibomian gland secretion scores (MGS), tear film break-up time (TBUT), OSDI, and the. SPEED ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12271009/

Dry Eye Disease Management Via Technological Methods

TearCare combined with meibomian gland expression (MGX) demonstrated the highest efficacy for improving meibomian gland secretion (SMD ...

7.

sciencedirect.com

sciencedirect.com/org/science/article/pii/S1874364123000280

MGrx - A Novel Multi-modal Thermal Device for Treating ...

A single 15-minute MGrx treatment was effective at significantly improving dry eye symptoms secondary to MGD in adult patients, as measured by SPEED score.

8.

researchgate.net

researchgate.net/publication/352694043_TearCare_for_the_Treatment_of_Meibomian_Gland_Dysfunction_in_Adult_Patients_With_Dry_Eye_Disease_A_Masked_Randomized_Controlled_Trial

(PDF) TearCare for the Treatment of Meibomian Gland ...

Conclusion These results suggest that single TearCare procedure is safe and effective in treating signs/symptoms of DED. Significant ...