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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is comparing two treatments for dry eye disease to see which is more effective and has fewer side effects.

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.Check my eligibility
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.See study design
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
Select...
Both of my eyes have blocked Meibomian glands.
Select...
I am 22 years old or older.
Select...
My eyes have blocked oil glands with a low secretion score.
Select...
I have been using eye drops regularly for dry eyes.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

Sight Sciences, Inc.Lead Sponsor
12 Previous Clinical Trials
665 Total Patients Enrolled

Media Library

TearCare System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795752 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the TearCare System been previously explored in research studies?

"At present, 67 studies are actively investigating the efficacy of TearCare System - 12 of which being Phase 3 trials. The majority are located in Aurora Colorado; however, there is a total of 470 sites conducting research on this system."

Answered by AI

What medical conditions does the TearCare System typically alleviate?

"TearCare System is frequently prescribed for transplantation, yet it can also help those with lupus nephritis, bulla and other conditions associated with excessive tearing."

Answered by AI

Is recruitment for this study still ongoing?

"This investigation has already concluded recruitment, with the first post dated April 23rd 2021 and the last update on September 12th 2022. If you are exploring other options, 147 studies for meibomian gland dysfunction and 67 trials for TearCare System currently have open positions."

Answered by AI

What is the maximum capacity of this medical research study?

"Alas, this trial is no longer enrolling. It was initially posted on April 23rd 2021 and last revised on September 12th 2022. As an alternative, there are 147 medical trials actively seeking candidates with meibomian gland dysfunction as well as 67 studies for the TearCare System that need participants."

Answered by AI

Are there multiple locations across Canada that are facilitating this experiment?

"This trial is available at a total of 14 different sites, including Lake Villa, Newport Beach and Laguna Hills. For ease of participation it is thus important to opt for the site that requires minimum travel from your current location if you decide to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Harvard Eye Associates
Doctor My Eyes
Scripps Health
Other
How many prior treatments have patients received?
3+
0
1

Why did patients apply to this trial?

I've applied for this study intending to support my dry eye condition. I go through 2 to 3 bottles of sustane in a 2 month period. I also use the night ****.
PatientReceived 2+ prior treatments
Restasis is what i have been using and over the counter eye drops . It doesn’t seem to be working very good.
PatientReceived 1 prior treatment
I have been diagnosed with meibomian gland disfunction since 2 yrs ago, my insurance does not cover treatment. I have used various drops with minimal success.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the trial medication? How long to be screened for the study?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)
2021. "Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04795752.
All > Sah > Restasis
~87 spots leftby Apr 2025
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