Johnson & Johnson Vision Announces Publication of Two Studies in Clinical Ophthalmology Demonstrating Effectiveness of LipiFlow® as Treatment of the Leading Cause of Dry Eye Disease

Monday, February 5, 2018 Clinical Trials News
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Data show LipiFlow® treatment increased average comfortable contact lens wearing time by approximately four hours for patients with meibomian gland dysfunction

SANTA ANA, Calif., Feb. 5, 2018 /PRNewswire/ -- Johnson & Johnson Vision announced today the simultaneous publication

of two studies in Clinical Ophthalmology demonstrating the patient and clinical benefits of LipiFlow® treatment for meibomian gland dysfunction (MGD), the leading cause of dry eye disease.

"Having a healthy ocular surface is the foundation for visual comfort, and an important factor for success in a variety of eye health treatments, including wearing contact lenses," explained investigator Kelly K. Nichols, OD, MPH, PhD, FAAO.  "A key to ocular surface homeostasis is the healthy meibomian gland, as it secretes an oil that prevents evaporation of the eye's tear film. When the meibomian gland is blocked, the result is often dry eye disease. With millions of patients in need, we wanted to better understand the current treatment options available for patients with contact lens discomfort."

In the first study1, a single LipiFlow® treatment significantly improved mean meibomian gland function and significantly reduced mean dry eye signs and symptoms from baseline to three months for soft contact lens wearers with MGD, compared to those in an untreated control arm. LipiFlow® treatment also increased comfortable contact lens wearing time by approximately four hours per day, on average. Consistent with previous clinical studies, no serious adverse events were found for LipiFlow®-treated eyes.

In the second study2, one 12-minute treatment with LipiFlow® was demonstrated to be significantly more effective than three months of doxycycline taken orally, daily, at improving dry eye symp­toms associated with MGD, based on the average change in reported dry eye symptoms from baseline. Doxycycline is indicated for the treatment of bacterial infections, including ophthalmic, and has been studied for use in MGD treatment. No adverse events related to LipiFlow® were reported.

"These results add to the growing body of evidence showing that one, 12-minute treatment with LipiFlow® can provide effective relief of the meibomian gland dysfunction and dry eye symptoms without serious side effects," said Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision. "We're proud to offer a proven, first-line option that may help improve eye health for the millions of people living with this chronic condition today."

MGD is the leading cause of dry eye disease. Dry eye affects more than 340 million people around the world, with an approximate 86% suffering from MGD.3,4,5 If left untreated, severe dry eye can result in damage to the surface of the eye with the potential to cause vision impairment.6 LipiFlow® restores meibomian gland function and relieves dry eye symptoms by gently applying heat and pressure to the eyelid to remove gland obstructions, while protecting delicate structures of the patient's eye.

LipiFlow® is available in nearly 1,000 optometrist and ophthalmologist offices in the U.S. and Canada. For more information about LipiFlow®, meibomian gland dysfunction, or to find a doctor near you, visit DryEyeandMGD.com.

Detailed Study Background   "A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day"1   The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens wearers with MGD and evaporative dry eye. Subjects were randomized to the single LipiFlow® treatment group or an untreated control. The controls received a crossover LipiFlow® treatment at three months. The primary and secondary endpoints were the mean change in meibomian gland secretion (MGS) and SPEED scores, respectively, from baseline to three months between the treated and untreated control groups. The treatment group had a statistically significant greater mean change (improvement) in MGS score (p<0.0001), the number of functional meibomian glands (p<0.0001), and SPEED score (p<0.0001) compared to the untreated control group. Similar improvements were observed in the crossover group assessed one-month post-treatment.

This study was sponsored by TearScience, part of Johnson & Johnson Vision.

"Comparison of a single-dose vectored thermal pulsation procedure with a 3-month course of daily oral doxycycline for moderate-to-severe meibomian gland dysfunction"2     The prospective, randomized, parallel-group, single-masked study included 28 subjects with moderate-to-severe MGD, who were randomized to receive either doxycycline treatment or a 12-minute LipiFlow® procedure in a 1:1 ratio. The subjects randomized to the doxycycline group were administered daily oral doxycycline for three months (100 mg twice daily [BID] for the first 14 days and 100 mg once daily for days 15–90). Those randomized to the LipiFlow® group received a single bilateral 12-minute procedure. The primary endpoints of the study were the Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire score and meibomian gland function score based on the number of meibomian glands yielding liquid secretion (MGYLS).  After 3 months, mean SPEED scores were significantly improved from their baseline values in both groups (p<0.005). The mean SPEED scores of the LipiFlow® group were significantly better than the doxycycline group at 3 months (p=0.030).  At 3 months, both the groups also demonstrated significant improvement in mean MGYLS scores from their baseline values (p<0.005). No statistically significant difference in the mean MGYLS scores was observed between the two study groups at 3 months (p=0.096).

This investigator-initiated study was funded with a grant from TearScience, part of Johnson & Johnson Vision.

About LipiFlow®    LipiFlow® is a treatment device specifically designed to remove blockages from the meibomian glands, allowing them to properly function and produce the oils that make up the top protective lipid layer of the tear film. Supported by 37 patents and used around the world by leading eye care professionals, LipiFlow® is fast becoming the standard-of-care for MGD with studies demonstrating safety and effectiveness. The LipiFlow® System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in: eyelid/eye pain requiring discontinuation of the treatment procedure; eyelid irritation or inflammation; ocular surface irritation or inflammation; and ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).

Johnson & Johnson VisionJohnson & Johnson Vision, through its operating companies, is committed to improving and restoring sight for patients worldwide. Since debuting the world's first disposable soft contact lens in 1987, Johnson & Johnson Vision Care, Inc. has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses portfolio. In 2017, with the addition of Abbott Medical Optics, Inc., the Johnson & Johnson Surgical Vision business, Johnson & Johnson invested further in eye health by expanding into cataract surgery, laser refractive surgery (LASIK) and consumer eye health. Serving more than 60 million patients a day across 103 countries, Johnson & Johnson Vision is committed to helping more people in more places improve or restore their sight. Dual headquartered in Jacksonville, Florida, and Santa Ana, California, Johnson & Johnson Vision has more than 10,000 employees worldwide.

References:

  1. Blackie CA, Coleman CA, Nichols KK, et al. A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day. Clinical Ophthalmology 2018:12 169–183.  
  2. Hagen KB, Bedi R, Blackie CA, Christenson-Akagi KJ. Comparison of a single-dose vectored thermal pulsation procedure with a 3-month course of daily oral doxycycline for moderate-to-severe meibomian gland dysfunction. Clinical Ophthalmology. 2018:12 161–168.  
  3. MarketScope: 2016 Dry Eye Products Report: A Global Market Analysis for 2015 to 2021: pg. 56.  
  4. Nichols KK, Foulks GN, Bron AJ, et al. The International Workshop on Meibomian Gland Dysfunction: Executive Summary. Investigative Ophthalmology & Visual Science. 2011;52(4):1922-1929.  
  5. Lemp MA, Crew LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478.
  6. Facts About Dry Eye. National Eye Institute. https://nei.nih.gov/health/dryeye/dryeye.  

 

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SOURCE Johnson & Johnson Vision



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