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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

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 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

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

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].

Find a Location

Who is running the clinical trial?

Sight Sciences, Inc.Lead Sponsor
13 Previous Clinical Trials
988 Total Patients Enrolled

Media Library

TearCare System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795752 — N/A
~81 spots leftby Sep 2025
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