Effectiveness of a single LipiFlow® treatment versus twice daily warm compresses and lid hygiene: a randomized, controlled, three month trial

Session Details

Session Title: Cornea Medical

Session Date/Time: Tuesday 16/09/2014 | 14:00-16:00

Paper Time: 14:12

Venue: Capital Hall A

First Author: : M.Jackson USA

Co Author(s): :                  

Abstract Details

Purpose:

Meibomian gland dysfunction (MGD) is currently understood to be the leading cause of dry eye through out the world. The LipiFlow® is the only device able to treat MGD by simultaneously heating and evacuating gland contents while also providing protection to the cornea and eyeball from heat and pressure during the treatment. A previous controlled clinical trial demonstrated safety and effectiveness of the LipiFlow® treatment for up to 1-month post treatment. The goal with this study was to assess the treatment effect of LipiFlow® in comparison to warm compresses and lid hygiene over a 3-month period in a randomized controlled clinical trial.

Setting:

Private ophthalmology practice

Methods:

This was a prospective, open-label, randomized, multicenter clinical trial. A total of 101 subjects were randomized to the LipiFlow® group and 98 subjects received a single LipiFlow® treatment in both eyes and one subject received treatment in one eye only (n=197 eyes). A total of 99 subjects were randomized to the Control group and 98 subjects received the control treatment of twice daily warm compresses and lid hygiene in both eyes (n=196 eyes). LipiFlow® subjects received a single 12- minute treatment. Control subjects were instructed to perform the warm compresses using the EyeGiene® System and lid hygiene using the OCuSOFT™ Lid Scrub twice daily for 3 months. Both groups were evaluated at Baseline, 1 month and 3 months. Effectiveness parameters of meibomian gland (MG) assessment and dry eye symptom questionnaire score. The study endpoint was to compare the mean change from Baseline to 3 months in these effectiveness parameters between the LipiFlow® and Control groups.

Results:

The intent to treat population was analyzed. Patient compliance with the twice daily warm compress and lid hygiene in the Control group was excellent overall. The age of the study population ranged from 22 to 85 years with a mean of 56.2 ± 15.3 years. The study population was 71% female and 29% male. The mean improvement in MG assessment for the LipiFlow® group was significantly greater than the Control group from baseline to 3 months (p<0.0001). Mean MG assessment at Baseline: LipiFlow®=6.2±3.7, Control=6.3±3.6; 1 month: LipiFlow®=17.3±11.2, Control=10.8±7.9; 3 months: LipiFlow®=17.8±10.6, Control=10.8±8.0. The LipiFlow® group also experienced a significantly greater mean reduction in symptoms from baseline to 3 months as compared with the Control group (p=0.007). Mean symptom score at Baseline: LipiFlow®=45.6±21.2, Control=51.8±23.2; 1 month: LipiFlow®=26.7±21.7, Control=34.7±23.8; 3 months: LipiFlow®=21.6±19.9, Control=33.6±25.6. Device-related adverse events reflected a low occurrence of non-serious, transient side effects with similar occurrence rates between the LipiFlow® and Control groups. No device related serious adverse events were observed.

Conclusions:

The study results validate the previously published 1-month effectiveness outcomes for LipiFlow® treatment. In addition, these results demonstrate that a single LipiFlow® treatment provides sustained effectiveness over the 3-month duration, as shown by a mean improvement in meibomian gland assessment and mean reduction in dry eye symptoms from baseline. Furthermore, a single 12-minute LipiFlow® treatment is significantly more effective than the diligent application of twice daily warm compresses and lid hygiene for 3 months. While a robust regimen of twice daily warm compress therapy and lid hygiene over a 3-month period can be efficacious, it is not as effective as a single LipiFlow® treatment, and excellent patient compliance with this regimen is unlikely outside of a clinical trial. The data also demonstrate that the benefits of the LipiFlow® System in providing simultaneous heat and pressure therapy in patients with MGD and dry eye symptoms outweigh the risks.

Financial Interest:

One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented