Abstract
Purpose :
To demonstrate the superiority of the TearCare system in improvement of dry eye disease (DED) symptoms associated with meibomian gland dysfunction (MGD) compared to LipiFlow.
Methods :
In this multi-center, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n=115) or a single LipiFlow treatment (n=120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI) Symptom Assessment in Dry Eye (SANDE), and eye dryness (ED) questionnaires at baseline and at 1-month. Subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS).
Results :
TearCare group and LipiFlow group had similar baseline mean OSDI (51.7 ± 14.79 and 51.7 ± 15.27). The reduction from baseline OSDI was 29.1 ± 1.62 for TearCare and 24.4 ± 1.59 for LipiFlow. The reduction in OSDI achieved with TearCare was significantly greater compared with LipiFlow (29.1 ± 1.62 vs 24.4 ± 1.59, pANCOVA = 0.04). Furthermore, subjects with more severe MGD (MGSS <7) achieved greater symptom-relief with TearCare compared to LipiFlow as shown in OSDI Section A (ocular symptoms), Section B (vision-related functions) and SANDE, pANCOVA < 0.05 for all comparisons.
Conclusions :
TearCare provides significant DED symptom relief at 1-month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.