A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease

Abstract

Purpose: To compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

Methods: In this multicenter, 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. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS).

Results: TearCare system significantly improved total OSDI, SANDE, and ED scores from baseline (p < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, p ANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, p ANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, p ANCOVA = 0.0455).

Conclusion: 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.

Clinical trial registration number: NCT03857919.

Keywords: TearCare procedure; dry eye disease; meibomian gland deficiency.

Conflict of interest statement

Kavita Dhamdhere is an employee of Sight Sciences, Inc. Jennifer Loh reports grants from Sight Sciences, during the conduct of the study; consultant and/or speaker for Johnson and Johnson, Sun Ophthalmics, Allergan, Kala Pharmaceuticals, and Imprimis, outside the submitted work. Vance Thompson and David Wirta reports personal fees/grants for research from TearClear, during the conduct of the study. The authors report no other conflicts of interest in this work.

© 2022 Holland et al.

Figures

Figure 1

TearCare demonstrated significant Ocular Surface Disease Index (OSDI) score reduction compared to LipiFlow in all subjects and in subgroup with Meibomian Gland Secretion Score (MGSS) pANCOVA = 0.0433). In subgroup with MGSS <7, the LS mean difference was 8.5 ± 3.47, 95% CI = (1.5, 15.4), pANCOVA = 0.0160. *Indicates statistically significant p values.

Figure 2

TearCare demonstrated significant Ocular Surface Disease Index (OSDI) Section A reduction in all subjects and OSDI Section B in subgroup with Meibomian Gland Secretion Score (MGSS) A) The reduction from baseline total OSDI score achieved with TearCare was significantly greater than the reduction achieved with LipiFlow (LS mean difference = 1.0 ± 0.44 (95% CI = [0.2, 1.9], pANCOVA = 0.0201). (B) In subgroup with MGSS <7, the LS mean difference was 1.5 ± 0.65, 95% CI = (0.2, 2.8), pANCOVA = 0.0206. *Indicates statistically significant p values.

Figure 3

TearCare provided better improvements in the following functions: driving at night, working with a computer or bank machine, and watching TV in subgroup with more severe disease. Bar graphs represent the mean reduction from baseline in OSDI score. Error bars represent the standard errors. (A) For driving at night, the LS mean difference was 0.5 ± 0.23, 95% CI = (0.0, 0.9]), pANCOVA = 0.0458. (B) For working with a computer or bank machine, the LS mean difference was 0.4 ± 0.21, 95% CI = (0.0, 0.8), pANCOVA = 0.0333). (C) For watching TV, the LS mean difference was 0.4 ± 0.16, 95% CI = (0.1, 0.8), pANCOVA = 0.0076. *Indicates statistically significant p values.

Figure 4

TearCare decreased dry eye frequency assessed by Symptom Assessment Questionnaire in Dry Eye (SANDE) in the subgroup with more severe disease. Bar graphs represent the mean reduction from baseline in SANDE frequency score. Error bars represent the standard errors The mean reduction from baseline in SANDE frequency score was 51.9 ± 3.70 (95% CI = [44.5, 59.2]) for the TearCare group and 41.5 ± 3.45 (95% CI = [34.7, 48.3]) for the LipiFlow group with LS mean difference = 10.4 ± 5.13 and pANCOVA = 0.0455. *Indicates statistically significant p values.