‘No clear evidence’ that LipiFlow outperforms other treatments for dry eye disease
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Key takeaways:
- Researchers found no significant evidence that LipiFlow outperforms other commonly used dry eye disease treatments.
- Further research is needed.
ATLANTA —There is limited evidence to show that LipiFlow is more effective than commonly used treatments for dry eye disease and meibomian gland dysfunction, according to recently published research.
“LipiFlow has been promoted as one of the best cures for meibomian gland dysfunction, because it warms the glands and pushes out the bad meibum,” Andrew D. Pucker, OD, PhD, FAAO, senior director of clinical and medical sciences at Lexitas Pharma Services, told Healio in an interview at SECO.
To evaluate the efficacy of the LipiFlow Thermal Pulsation System (Johnson & Johnson) vs. other treatments for meibomian gland dysfunction (MGD), Pucker and colleagues searched several electronic databases for relevant trials conducted on adults with dry eye disease or MGD.
They included 13 studies with a total of 1,155 randomized participants (aged 19 to 86 years; 66% women; 1,720 eyes), six of which were conducted in the U.S., three in China, two in Thailand, one in France and one in Italy. Eight trials used a single-center design, while four trials were multicenter, and one did not report the number of participating locations.
LipiFlow as a standalone intervention was compared with warm compresses in five studies, with thermostatic devices in five studies, with oral doxycycline in one study and with topical lifitegrast 5% in one study. One study also examined LipiFlow in conjunction with an eyelid hygiene product compared with hygiene products alone.
When researchers analyzed symptom scores using the Ocular Surface Disease Index and Standard Patient Evaluation of Eye Dryness (SPEED), they found no evidence of differences in meibomian gland expression, meibum quality or tear breakup time between LipiFlow and basic warm compresses.
“We found no clear evidence that LipiFlow performs better than warm compresses,” Pucker said. “This was surprising to probably everyone. People pay hundreds of dollars for the treatments.”
In trials comparing LipiFlow with thermostatic devices, OSDI scores at 4 weeks improved by a mean difference of 4.59 with thermostatic devices, although the certainty of evidence was low. There also was no evidence that LipiFlow used in conjunction with eyelid hygiene yielded a difference in signs or symptoms vs. eyelid hygiene alone.
The trial comparing LipiFlow with topical 5% lifitegrast indicated that the topical treatment may increase meibomian gland expression scores at day 42. The study comparing LipiFlow with doxycycline showed that LipiFlow may improve SPEED scores more, although certainty of evidence was low, and no other significant differences in signs or symptoms were reported at 3 months.
Pucker and colleagues found no evidence that LipiFlow is unsafe or causes adverse events.
“Dry eye is hard to do meta-analysis on,” Pucker told Healio. “Investigators use different tests, and the data were a little messy. Better trials are needed, and we need to do this study again to see if it truly is about the same as other treatment.”