An interventional study of TearCare® in Meibomian Gland Dysfunction (Disorder), sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment.
Co-primary efficacy endpoints include change from baseline in non-invasive keratograph break-up time (NIKBUT) at Day 28 and change from baseline in ocular surface disease index (OSDI) at Day 28. Secondary endpoints include the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. Exploratory endpoints include change from baseline in Dry Eye-Related Quality of Life Score (DEQS) at Day 28. The primary safety endpoint is the incidence of adverse effects that are probably or definitely related to the intervention.
The study population will include 45 young adults with clinically significant MGD (30 participants who are ≥18 to \<22 years of age and 15 participants who are ≥22 to \<30 years of age). The study duration is 4 weeks. TearCare® eyelid warming and manual gland expression will be performed once at Visit 1.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of any of the following medications within 60 days of enrollment:
Any of the following procedural treatments for MGD in the past:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TearCare® eyelid warming and manual gland expression performed once at Visit 1 and followed for 4 weeks. All participants will undergo standardized ocular assessments including OSDI questionnaires, non-invasive keratograph break-up time, Habitual High contrast LOGMAR Visual Acuity, Bio microscopy, posterior lid margin hyperemia, Fluorescein tear break-up time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy with lissamine green, Surveys - DEQS, SANDE, Screen time-use, Lipview II lipid imaging, Keratograph R-scan, Keratograph Meibography, meibomian gland expression by meibomian gland evaluator.
Device: TearCare®
The TearCare system is designed to deliver controlled, precise heat to the tarsal plates and underlying MGs of the eyelids for 15 minutes. The TearCare system comprises a reusable Smart-hub and single-use Smart-lids. The single-use Smart-lid pair comprises four flexible, sensor-controlled strips that adhere to each of the four eyelids. They contain flexible circuits, sensors, and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical-grade adhesive on the skin-facing surface of the Smart-lids allows them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The Smart-lids are connected to the Smart-hub. When attached to the Smart-hub, the Smart-lids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensure that the temperature delivered at the eyelids is maintained within a precise range.
Ocular Surface Disease Index (OSDI) Score From Baseline to 4 Weeks
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess dry eye symptoms and their impact on vision-related functioning. Total scores range from 0 to 100, with higher scores indicating greater symptom severity and worse outcomes. The change in OSDI score from baseline to Week 4 will be assessed.
Time frame: Baseline to 4 weeks
Non-Invasive Keratograph Break-Up Time (NIKBUT) From Baseline to Week
Non-Invasive Keratograph Break-Up Time (NIKBUT) refers to an imaging modality used to image the pre-corneal tear film and measure the time it takes for the tear film to destabilize or break up. Change in NIKBUT from baseline to Day 28 will be assessed.
Time frame: Baseline to Week 4
Plan to share: No — Individual participant data (IPD) will not be shared outside of the study team, sponsor, or regulatory agencies. Participant data will be used only for analysis related to this study and may be reviewed by authorized representatives of the sponsor (Sight Sciences, Inc.), the University of Alabama at Birmingham Institutional Review Board (IRB), and regulatory authorities as required by law. De-identified summary results may be shared in aggregate form in publications or presentations, but no individual-level data will be made publicly available.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
Of 52 non-industry interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 9 months is below that.
Counting every sponsor, half of 74 studies reached it within 11 months; a quarter within 5 and three quarters within 19.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →