New 24-month results from Stage 3 of the SAHARA randomized controlled trial (RCT) support the long-term durability of Sight Sciences’ TearCare procedure for dry eye disease (DED) treatment.
The data was released ahead of publication in Optometry and Vision Science.
Let’s begin with TearCare.
Granted FDA 510(k) clearance in 2021, the TearCare System is indicated for use in adult patients diagnosed with evaporative DED due to meibomian gland dysfunction (MGD)—specifically in conjunction with manual expression of the meibomian glands (MGs).
- Designed as wearable and smart technology, the in-office treatment provides localized heat therapy to address the underlying root cause of MGD: obstructed MGs.
Explain this heat therapy.
It’s based on Thermal-Activated Restorative Gland Expression Therapy (TARGET) technology, which restores the natural function of the MG to treat those obstructed meibomian glands.
Here’s a breakdown of its two key components:
- Thermal activation: Delivers controlled thermal energy to soften gland obstructions
- Restorative gland expression: Allows eyecare providers (ECPs) to precisely express glands and restore their natural function
Now to the treatment itself.
- First: Localized heat is applied to the eyelid to melt and express the thickened oils that clog the glands
- Then: This is followed by the removal of blockages from the MGs using expression forceps (to ensure any residual MG obstruction is cleared).
The intended result: A more precise and controlled delivery of that energy to the eyelids—along with two forms of MG obstruction expression:
- Natural blinking expression
- Mechanical expression (performed by an ECP)
So what comes with this system?
The single-use treatment kit is equipped with four electrothermal (SmartLid) devices adhesively affixed to the tarsal plate of each eyelid.
About these devices:
- They are shaped to conform to the eyelid’s anatomy, allowing patients to blink while undergoing treatment.
- They connect via a cable to the proprietary TearClear controller, enabling regulated and targeted thermal energy to be delivered across the eyelids.
- This thermal energy is delivered at a consistent therapeutic temperature range between 41°C–45°C.
And how long does treatment take?
An estimated 12 minutes (in-office and non-invasive, remember).
Got it. Now let’s talk about this SAHARA trial.
This is the first multicenter, prospective RCT (NCT04795752) that has evaluated interventional eyelid procedures (enabled by TearCare) compared to Restasis (cyclosporine ophthalmic emulsion, 0.05%) eye drops administered twice a day (BID).
A few details on its setup:
- The participants: 350 patients (aged 22+) diagnosed with dry eye (with regular artificial tear use)
- See here for full inclusion and exclusion criteria
- The setup: Patients randomized to receive either:
- Treatment with the TearCare System followed by manual MG expression within 7 days of baseline and 5-month visits
- Starting at 9 months: They received an additional TearCare procedure if:
- Tear breakup time (TBUT) drops were lower than baseline or within 2 seconds of baseline and / or if Ocular Surface Disease Index (OSDI) worsens by at least 1 category
- Starting at 9 months: They received an additional TearCare procedure if:
- Treatment with the TearCare System followed by manual MG expression within 7 days of baseline and 5-month visits
- Restasis, administered as one drop, twice a day (BID) from baseline through the Month 6 visit, after which they were crossed over to receive one TearCare procedure and tracked an additional 18 months (for 24 months in total)
And what was measured?
Two key outcomes, each initially measured at 6 months:
- TBUT (mean change from baseline; primary endpoint)
- OSDI score (mean change from baseline)
Before we get to these new findings, what did the initial 6-month data look like?
In this first stage, the study met its primary endpoint, demonstrating TearCare’s “superiority of interventional eyelid procedures” compared to Restasis for TBUT improvement.
And as we previously reported, TearCare-treated patients also achieved “clinically and statistically significant improvements” at all time intervals (1 week as well as 1, 3, and 6 months) for:
- TBUT
- MG secretion score (MGSS)
- Corneal and conjunctival staining
See here for more details—and check out the 12-month (Stage 2) findings, which followed and evaluated Restasis-treated patients who crossed over to TearCare for an additional 6 months (hint: those initial improvements continued without the need for further Restasis use).
Next up: 24-month data.
To start: A total of 166 patients were included in this final stage of the study.
As for the findings: All mean DED signs and symptoms (TBUT) remained “statistically significantly better than the study baseline” for all time points measured through to 24 months.
- The numbers to know:
- 66% of patients who received TearCare treatment at baseline and the Month 5 visit required no additional treatment
- Mean TBUT ranged from 6.29 to 7.13 seconds compared to the baseline of 4.41 seconds (all p < 0001).
Zero in on MGSS.
Meibum quality and quantity (measured via MGSS) improvements originally noted at the 6-month point (from baseline) following two TearCare treatments continued through 24 months.
- 6-month data: 7.26 to 18.95
- 24-month data: 17.68 to 18.95
- (p < 0.0001 at all timepoints measured vs baseline)
These improvements—specifically “clinically meaningful and statistically significant”—were also observed and sustained through 24 months for:
- The number of MGs yielding any liquid (MGYAL) and clear liquids (MGYCL)
- Anesthetized Schirmer tear scores
- Conjunctival and corneal staining scores
Now to symptom assessments.
Based on evaluations by OSDI, symptom assessment in dry eye (SANDE), and the eye dryness score (EDS), “all subjects remained near the values at Month 6” for all follow-up timepoints (p < 0.0001).
Case in point:
- 6-month values: 31.9 (OSDI; 40.2 (SANDE); 39.9 (EDS)
- 24-month values: 50.3 (OSDI; 66.8 (SANDE); 65.1 (EDS)
Investigators’ insight on this: They deemed these improvements “of particular importance,” as they indicated patients’ direct feedback on how their eyes felt and how DED impacted their lives.
So what did they conclude from this latest data?
Based on the findings, John Hovanesian, MD, lead author of the study, noted TearCare’s delivery of dry eye relief that’s “immediate, powerful, repeatable, and long-lasting.”
- “Studies of this scale and rigor are uncommon in ocular surface disease,” he added, “and our findings show that just two TearCare treatments within 5 months can result in meaningful, lasting improvements for up to 2 years—a significant step forward for patients living with [DED].”