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: firstname.lastname@example.org).
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