In the extension of an initial 6-month study of TearCare for adults with clinically significant dry eye disease, researches observed that after 12 months of treatment, patients showed additional improvement in their dry eye sign and symptoms after the 6-month treatment.
SightSciences’ TearCare, an in-office treatment that delivers thermal energy to the eyelids, is indicated for use in meibomian gland dysfunction (MGD), dry eye and blepharitis. However, TearCare has not yet cleared by FDA for treating dry eye disease, according to a company press release.
“While it is widely prescribed, warm compress therapy for the treatment of MGD or evaporative dry eye suffers from many shortcomings,” the study authors wrote. “It has been shown that it is challenging to achieve and maintain therapeutically warm (greater than 40° C) compresses in the clinic or at home.
“For instance,” they continued, “the compress may be too cool initially or may cool off too quickly. On the other hand, a compress that is too warm may cause injury to the eyelid or even the eye.”
In the initial 6-month study, patients were randomized into two groups: TearCare treatments or daily warm compress therapy. At 6 months, patients were evaluated for the effectiveness of the treatment as well as the durability and safety of retreatment for an additional 6 months, according to the study. Researchers re-administered TearCare to those who had initially received it in 12-minute thermal eyelid treatments followed by a manual meibomian gland clearance.
According to the study, the primary effectiveness end point was the tear break-up time (TBUT) from baseline to 1 month. Secondary end points were assessed as meibomian gland scores, corneal and conjunctival staining scores, and assessment of dry eye symptoms.
After retreatment, researchers recorded significant improvements from baseline TBUT at the 1-month clinical visit. This change represented a 12.4-second (±3.3 seconds) improvement.
Collaborators also noticed significant improvements in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of DED.
“For the millions of patients who suffer from dry eye disease, TearCare is the most personalized procedure that offers a natural-blink design, ultra-precise meibomian gland clearance and a smart control system,” Edward Holland, MD, professor of clinical ophthalmology at the University of Cincinnati and a Sight Sciences advisor, said in the release. “The findings of this study reinforce our optimism that with this innovative technology, eye care professionals can maintain a regular course of treatment that is right for their patients.”
In the initial study, researchers showed that TearCare provided better efficacy over its 6-month trial than a daily warm compress for reducing the symptoms of DED. Because MGD is a chronic disease, after the initial 6-month treatment, symptoms would return over time, thus, an extended investigation into the efficacy of retreatment was necessary, according to the study. – by Scott Buzby
Disclosure: Badawi is an employee of Sight Sciences. The study was sponsored by Sight Sciences, which participated in its design and data collection. Sight Sciences also reviewed the manuscript for accuracy and assessment of the presentation of any proprietary information.