A new, single center, prospective clinical study published in the January issue of Clinical Ophthalmology provides preliminary evidence that retreatment with the Sight Sciences TearCare System is a safe and effective treatment for dry eye disease, according to a company news release. The TearCare System is indicated for use in meibomian gland dysfunction (MGD), dry eye, and blepharitis, but is not yet cleared by FDA for the treatment of the signs and symptoms of dry eye disease (DED). A large, prospective, multicenter, randomized controlled trial will begin enrolling in the first quarter of 2019.
In this continuation of the initial 6 month, single center, pilot clinical trial that was published in 2017, 12 patients were re-treated after the 6 month follow-up, and continued to experience a significant improvement in all dry eye signs (tear breakup time (TBUT), corneal and conjunctival staining, and Meibomian gland scores) and symptoms (SPEED, OSDI, and SANDE) through 12 months.
At a 1-month clinic visit following retreatment, the primary signs endpoint (TBUT) increased by 12.4 (±3.3) seconds (P<0.001) over baseline. On dry eye symptoms, subjects had a reduction in SPEED scores after the second TearCare treatment from a baseline score of 15.7±5.2 to a final score of 7.9±6.7 (P=0.004 compared to Day 0) 6 months later. The study findings concluded TearCare provided long-term improvement in the signs and symptoms of dry eye disease.*
“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, University of Cincinnati and a Sight Sciences advisor, said in a company news 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.”
TearCare is the world’s first and only wearable therapeutic eyelid technology providing a personalized open eye experience. The TearCare treatment allows the patient’s eyes to remain open and blinking during the procedure. Soft, flexible thermal devices conform to the eyelids to deliver a therapeutic level of energy for a specific period of time to liquefy meibum, an oily coating on the eye surface which prevents tear film evaporation.
“The completion of this prospective study is a significant milestone for Sight Sciences and provides compelling early validation of our leading-edge TearCare technology,” Paul Badawi, Chief Executive Officer and Founder of Sight Sciences, said in the news release. “With a mission to transform eye care by developing and commercializing devices that comprehensively target the underlying physiology of the world’s leading eye diseases, TearCare fulfills our ultimate corporate goal of generating excellent experiences and clinical outcomes for ECPs and their patients.”