TearCare for Meibomian Gland Dysfunction

SG
UO
Overseen ByUAB Optometry Clinical Research (205) 934-6734
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test TearCare®, a treatment for meibomian gland dysfunction (MGD), which often causes dry and irritated eyes. The study will evaluate the effectiveness of this eyelid warming and gland expression treatment over four weeks. Participants will undergo a follow-up examination after the initial treatment to assess changes in their symptoms. Individuals who have experienced dry eyes and discomfort due to MGD, and have not recently used certain eye medications or treatments, might be suitable candidates for this study. As an unphased trial, this study provides an opportunity to explore new treatment options for MGD and contribute to advancing eye care research.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. Specifically, you cannot use certain eye medications like cyclosporine, Xiidra, Miebo, Tyrvaya, or Tryptyr within 60 days before joining the trial. Also, you should not use topical ocular steroids within 30 days, other eye drops (except artificial tears) within 7 days, or certain oral antibiotics within 30 days.

What prior data suggests that the TearCare® device is safe for treating meibomian gland dysfunction?

Research has shown that the TearCare® system is generally safe for treating meibomian gland dysfunction (MGD), a common eye condition. The FDA has cleared the system, confirming its safety and effectiveness for this treatment. Studies have found that TearCare® eases symptoms of dry eye disease without major safety concerns.

Some individuals might experience mild side effects, such as swelling or redness of the eyelids. These effects are not harmful and usually resolve quickly. The treatment applies heat to the eyelids, enhancing the function of glands that produce the oily part of tears, which can reduce dryness and irritation.

Overall, TearCare® is well-tolerated, and most people do not experience serious side effects. It offers a safe option for those dealing with dry eye issues related to MGD.12345

Why are researchers excited about this trial?

TearCare® is unique because it offers a targeted approach to treating Meibomian Gland Dysfunction by using eyelid warming and manual gland expression. Unlike traditional methods like warm compresses or medications that may take time to show effects, TearCare® provides immediate warming directly to the eyelids, aiming for more efficient gland unclogging. Researchers are excited about this treatment because it promises quicker relief and potentially more consistent results by precisely targeting the root cause of the dysfunction.

What evidence suggests that TearCare® is effective for meibomian gland dysfunction?

Research has shown that TearCare can help treat meibomian gland dysfunction (MGD), a major cause of dry eye. In this trial, participants will receive a single TearCare treatment. Previous studies have demonstrated that this treatment can reduce the need for lubricant eye drops by 22% more than LipiFlow. Patients reported significant improvement just one month after treatment. Another study found that the benefits of one treatment could last up to 12 months, enhancing both gland function and overall eye comfort. Additionally, TearCare has received FDA clearance, supporting its effectiveness for MGD.16789

Who Is on the Research Team?

JF

Jillian F Ziemanski, OD, PhD, FAAO

Principal Investigator

The University of Alabama at Birmingham, School of Optometry

Are You a Good Fit for This Trial?

This trial is for young adults who have significant problems with their meibomian glands, which can cause dry eyes and eyelid inflammation. Participants should not have other eye conditions or factors that could interfere with the study.

Inclusion Criteria

OSDI ≥23
Non-invasive Keratograph break-up time (NIKBUT) <10 seconds in at least one eye
Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid
See 1 more

Exclusion Criteria

Current or planned lactation during the study period
Contact lens wear within two weeks of study enrollment or planned during study period
Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

TearCare® eyelid warming and manual gland expression performed once at Visit 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) at Day 28

What Are the Treatments Tested in This Trial?

Interventions

  • TearCare®

Trial Overview

The study tests TearCare®, a device that gently warms the eyelids to help open blocked oil glands, followed by manual gland expression. All participants receive this treatment once, with a follow-up after about four weeks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Sight Sciences, Inc.

Industry Sponsor

Trials
14
Recruited
1,000+

Citations

Effectiveness of TearCare System in Improvement Dry Eye ...

Conclusions : TearCare provides significant DED symptom relief at 1-month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments.

United States

TearCare patients in the SAHARA trial benefitted from improved function of obstructed and diseased meibomian glands and experienced rapid ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37585853/

Localized Heat Treatment for Meibomian Gland Dysfunction

A single TearCare treatment effectively reduced both the symptoms and signs of MGD and maintained its effects for 12 months.

Study: Improvements in signs and symptoms of dry eye ...

Further, it was noted in the news release that data showed that patients experienced a 44% decrease in dry eye symptoms from baseline to week 8, ...

TearCare for the Treatment of Meibomian Gland Dysfunction ...

A single TearCare treatment resulted in a significantly greater reduction (22% more; P < 0.01) in lubricant drop use compared with a single LipiFlow treatment ( ...

Sight Sciences Receives FDA 510(k) Clearance of ... - Tearcare

Sight Sciences receives FDA 510(k) clearance of the TearCare® system for treatment of meibomian gland dysfunction (MGD), the leading cause of dry eye disease.

K231084.pdf - accessdata.fda.gov

The TearCare MGX™ System is a powered device intended for the application of localized heat therapy in adult patients with evaporative dry eye ...

TearCare Important Product Information - United States

The TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to MGD.

TearCare® system extension study: evaluation of the safety ...

Evaluation of the safety and effectiveness of a TearCare® retreatment in adult subjects with clinically significant dry eye disease (DED).