What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome, particularly those targeting Meibomian Gland Dysfunction like TearCare®'s localized heat therapy, include warm compresses, thermal pulsation, and intense pulsed light (IPL) therapy. Known side effects of these treatments are generally mild and may include temporary redness, irritation, or discomfort in the treated area. In rare cases, patients might experience more persistent symptoms or minor burns. Overall, these therapies are well-tolerated and effective in improving symptoms of DES.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome, particularly those targeting Meibomian Gland Dysfunction. One notable treatment is the LipiFlow® Thermal Pulsation System, which uses a combination of localized heat and pressure to clear blocked meibomian glands. Additionally, the FDA has approved various pharmacological treatments such as cyclosporine ophthalmic emulsion (Restasis®) and lifitegrast ophthalmic solution (Xiidra®), which help increase tear production and reduce inflammation. More recently, varenicline nasal spray has been approved to stimulate tear production. These treatments, along with the TearCare® system, provide a range of options for managing Dry Eye Syndrome.

What other types of research exist?

Promising alternatives to TearCare® for Dry Eye Syndrome patients include: 1) Topical cyclosporine A 0.05% (tCsA), which has shown significant improvement in lid margin vascular injection, tarsal telangiectasis, and meibomian gland inclusions. 2) Intense Pulsed Light (IPL) therapy, which has demonstrated efficacy in improving signs and symptoms of MGD, especially when combined with meibomian gland expression (MGX). 3) BroadBand Light Intense Pulsed Light (BBL-IPL) therapy, which has been effective in reducing the frequency of hordeolum and blepharitis in patients with MGD. 4) Laser Acupuncture (LA), which has improved tear film stability and symptoms of Dry Eye Disease (DED) when used alongside conventional treatments.

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Device

TearCare System vs Restasis for Dry Eye Disease

N/A

Waitlist Available

Research Sponsored by Sight Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.

At least 22 years of age

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial compares the safety and effectiveness of TearCare®, a heat-based eyelid treatment, with Restasis®, an anti-inflammatory eye drop, in treating dry eye disease in adults. Restasis is an eye drop containing cyclosporine A and is the first approved treatment for dry eye.

Who is the study for?

Adults over 22 with dry eye symptoms for the past 3-6 months, poor tear production and quality, and blocked meibomian glands. They must not have used certain dry eye treatments recently or have a history of specific eye surgeries or conditions that could affect the trial results.

What is being tested?

The study is testing the safety and effectiveness of TearCare®, a device designed to treat dry eyes, compared to Restasis®, an established medication for this condition. Participants will be randomly assigned to one of these two treatments.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort during treatment with TearCare® or typical drug-related reactions such as burning or irritation from Restasis®.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Both of my eyes have blocked Meibomian glands.

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I am 22 years old or older.

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

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I have been using eye drops regularly for dry eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe front eyelid inflammation but not with excessive flakes.

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I have noticeable eyelid issues in either eye.

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I have not had eye surgery in the last year or any major eye surgeries before that.

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I have used Accutane before.

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I haven't used any antihistamines in the last 10 days.

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My medication causing dry eyes has had a stable dose for the last 30 days.

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I haven't used the TrueTear device in the last 2 weeks.

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I have a significant skin condition affecting my eyelid or around my eye.

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I do not have any eye infections or inflammation.

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I have used eye drops like Restasis or Xiidra in the last 60 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

OSDI Score

Tear Break-Up Time

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TearCare Group (Study Device)Experimental Treatment1 Intervention

Group II: Restasis Group (Control)Active Control1 Intervention

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dry Eye Syndrome (DES) include localized heat therapy, topical antibiotics, and anti-inflammatory agents. Localized heat therapy, such as TearCare®, warms the eyelids to liquefy and express the meibomian gland secretions, enhancing tear film stability. Topical antibiotics reduce bacterial load, decreasing inflammation and infection risk. Anti-inflammatory agents, like cyclosporine, reduce ocular surface inflammation, improving tear production and quality. These mechanisms are vital for DES patients as they target the root causes of tear film instability and inflammation, providing symptomatic relief and improving overall quality of life.

Dry Eye Disease: A Review of Epidemiology in Taiwan, and its Clinical Treatment and Merits.Six-month effects of a thermodynamic treatment for MGD and implications of meibomian gland atrophy.[Efficacy of physiotherapy and hygienic procedures in treatment of adults and children with chronic blepharitis and dry eye syndrome].