• Cornea/External Disease

    A randomized controlled trial examines the difference between a single treatment of TearCare or Lipiflow to treat patients with meibomian gland disease and dry eye.

    Study design

    This was a multicentered, masked, randomized controlled trial. A total of 135 subjects with dry eye symptoms over 3 months received either a single TearCare (n = 67) or a single Lipiflow (control arm, n = 68) treatment and were followed for 1 month post-treatment.

    Outcomes

    One month after treatment with either Lipiflow or TearCare, both groups demonstrated significant improvements in mean tear film break-up time and meibomian gland secretion score. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced with both treatments. There were no statistically significant differences for any result between the groups, but the TearCare group consistently demonstrated numerically greater improvements in all signs and symptoms of dry eye.

    Limitations

    Limitations of this study include limited patient follow-up time after treatments (1 month only), and the subjective nature of primary endpoints (i.e., clinician-determined tear break-up time, corneal and conjunctival staining, and meibomian gland function, as well as patient-reported dry eye symptoms in questionnaire responses). Objective endpoints such as changes in meibography or non-invasive tear break-up time could be helpful in the future to assess the efficacy of each treatment modality. Patient selection also was limited only to patients who were previously treated with artificial tears only, which is not representative of many dry eye patients who are often on multiple modalities of treatments and require thermal pulsation as an adjunctive therapy to their current regimen.

    Clinical significance

    With many currently available thermal pulsation treatment options for patients with meibomian gland dysfunction and evaporative dry eye, clinicians need to understand which treatment is best for a given patient. This study shows that TearCare treatment is non-inferior to Lipiflow for the treatment of meibomian gland disease and evaporative dry eye. This provides clinicians the opportunity to offer patients different yet effective therapies for their dry eye disease depending on accessibility to treatment devices and patient preferences.