Johnson & Johnson Vision Announces Publication of Two Studies in Clinical Ophthalmology Demonstrating Effectiveness of LipiFlow as Treatment of MGD

Source: Johnson & Johnson Vision

Monday, February 05, 2018 | Clinical Trials , Dry Eye , Johnson & Johnson Vision Care


Johnson & Johnson Vision announced 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," investigator Kelly K. Nichols, OD, MPH, PhD, FAAO, said in a company news release. "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 study,1 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 study,2 one 12-minute treatment with LipiFlow was demonstrated to be significantly more effective than 3 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," Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision, said in the news release. "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."

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 3 months. The primary and secondary endpoints were the mean change in meibomian gland secretion (MGS) and SPEED scores, respectively, from baseline to 3 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.

 

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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