CompletedNot Applicable

TearCare System to Treat Dry Eye Disease

United States235 participantsStarted 2019-03-03

Plain-language summary

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Restasis or Xiidra within 60 days prior to enrollment;
. Antihistamines (oral or topical) within 10 days prior to enrollment;
. Systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
. Accutane (at any time);
. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment.
. Office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment;
. Meibomian gland expression within 6 months prior to enrollment;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Tear Break-Up Time (TBUT) From Baseline

Timeframe: 1 month

Change in Meibomian Gland Secretion Score From Baseline

Timeframe: 1 month

Trial details

NCT IDNCT03857919

SponsorSight Sciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-17

Results submitted2023-10-25

View on ClinicalTrials.gov More Dry Eye trials