MORRISVILLE, N.C.--(BUSINESS WIRE)--The results of a randomized, controlled clinical study of a new treatment for Meibomian Gland Dysfunction (MGD) and evaporative dry eye disease, using the LipiFlow® Thermal Pulsation System, was reported in Cornea to provide sustained improvement, on average, in both signs and symptoms. Further, this study demonstrated the clinical utility, safety and effectiveness of LipiFlow® in adult patients with MGD and dry eye symptoms.
“A New System, the LipiFlow, for the Treatment of Meibomian Gland Dysfunction (MGD),” which will be published in the April 2012 issue of Cornea (31:396-404), was co-authored by Stephen S. Lane, MD; Harvey B. Dubiner, MD; Randy J. Epstein, MD; Paul H. Ernest, MD; Jack V. Greiner, DO, PhD; David R. Hardten, MD; Edward J. Holland, MD; Michael A. Lemp, MD; James E. McDonald II, MD; David I. Silbert, MD; Caroline A. Blackie, OD, PhD; Christy A. Stevens, OD, MPH; and Raman Bedi, MD. The article can be accessed for free online at Cornea’s web site.
The clinical study was supported by TearScience® and involved nine U.S.-based investigational centers and 139 patients (278 eyes). It compared results for patients treated with a single LipiFlow® treatment to a warm compress control for the treatment of MGD. The average total Meibomian gland score for patients who received a single LipiFlow® treatment more than doubled from 6.3 ± 3.5 at the baseline to 16.7 ± 8.7 at 4 weeks. The increase in the average total Meibomian score reflected an improvement in both the quality and quantity of Meibomian glands secreting lipids, which keep the water portion of tears from evaporating too quickly, as compared to before the LipiFlow® treatment. Two different recognized symptom questionnaires were used in the study: the Standard Patient Evaluation of Eye Dryness (SPEED) and the Ocular Surface Disease Index (OSDI). The average total SPEED score for patients who received a single LipiFlow® treatment decreased from 14.3 ± 4.8 at the baseline to 7.6 ± 5.8 at 4 weeks, demonstrating a mean reduction in dry eye symptoms. Similarly, the average OSDI score decreased from 32.0 ± 20.0 at baseline to 16.6 ± 18.1 at 4 weeks.
In the study, there were no serious device-related adverse events reported for the LipiFlow® System. Non-serious device-related adverse events included moderate eyelid pain during treatment (3eyes) and transient, moderate eye redness after treatment (1 eye).
“Managing dry eye disease has recently emerged as a hot topic in ophthalmology,” said Stephen S. Lane, MD of Associated Eye Care in Stillwater, Minnesota. “To date, both dry eye patients and physicians have been frequently frustrated with traditional treatment options. The size and control of this study coupled with the outstanding results make this one of the most encouraging treatments for Meibomian Gland Dysfunction and evaporative dry eye sufferers since I became an ophthalmologist. Results this encouraging are often seen in single-center studies but may not be confirmed when subjected to a large multi-center, controlled clinical trial such as this.”
LipiFlow®, which applies heat and gentle pressure to a patient’s eyelid, is designed to liquefy and evacuate obstructions in Meibomian glands during a 12-minute in-office procedure. The goal of unblocking the glands is to allow them to resume their natural production of lipids required for a healthy tear film. TearScience® manufactures and sells a complete system for eye care physicians, which is comprised of the LipiFlow® and the LipiView® Ocular Surface Interferometer, which allows physicians to assess a patient’s tear film.
“TearScience®’s focus is to provide physicians the ability to help their patients who are plagued by chronic evaporative dry eye,” said Brian Regan, vice president of Marketing and Market Development for TearScience. “LipiFlow®, which addresses a root cause of evaporative dry eye, the obstructed Meibomian glands, is a dramatic shift from traditional dry eye symptom management.”
About TearScience, Inc.
Headquartered in Morrisville, North Carolina, TearScience has pioneered devices that provide significant clinical improvement in the treatment of evaporative dry eye. Of the more than 100 million dry eye sufferers worldwide, approximately 86 percent have evaporative dry eye, which is caused by Meibomian Gland Dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film. The Tear Film and Ocular Surface Society (TFOS) workshop, involving two years of work by 50 leading experts from around the world, concluded that MGD is an under-estimated condition and is very likely the most frequent cause of dry eye disease. Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances. TearScience’s integrated, in-office system enables eye care professionals to effectively address a root cause of evaporative dry eye, obstructed Meibomian glands. For additional information, visit www.tearscience.com.