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A New System, the LipiFlow, for the Treatment of Meibomian Gland Dysfunction

Lane, Stephen S. MD; DuBiner, Harvey B. MD; Epstein, Randy J. MD; Ernest, Paul H. MD; Greiner, Jack V. DO, PhD; Hardten, David R. MD; Holland, Edward J. MD; Lemp, Michael A. MD; McDonald, James E. II MD; Silbert, David I. MD; Blackie, Caroline A. OD, PhD; Stevens, Christy A. OD, MPH; Bedi, Raman MD

doi: 10.1097/ICO.0b013e318239aaea
Clinical Science

Purpose To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD).

Methods This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort.

Results LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events.

Conclusion The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

*Associated Eye Care, Stillwater, MN

Clayton Eye Center, Morrow, GA

Chicago Cornea Consultants, Ltd., Highland Park, IL

§TLC Eyecare & Laser Centers, Jackson, MI

Charles River Eye Associates, Winchester, MA

Minnesota Eye Consultants, Bloomington, MN

#Cincinnati Eye Institute, Edgewood, KY

**Georgetown University, Washington DC

††McDonald Eye Associates, Fayetteville, AR

‡‡Family Eye Group, Lancaster, PA

§§TearScience Inc., Morrisville, NC

‖‖Iris Advanced Eye Centre, CMC Hospital, Chandigarh, India

Reprints: Caroline Blackie, OD, PhD, 400 Commonwealth Ave, Unit #2, Boston, MA 02215 (e-mail: cblackie@tearscience.com).

Financial Support: This study was funded by TearScience Inc., Morrisville, NC.

CB and CS are employees of TearScience Inc.; RB is a paid consultant of TearScience Inc.; ML is the medical monitor for TearScience Inc. None of the other authors have any financial affiliation to TearScience Inc.

Received September 13, 2010

Accepted May 31, 2011

Copyright © 2012 Wolters Kluwer Health, Inc. All rights reserved.