TearCare(®) system extension study: evaluation of the safety, effectiveness, and durability through 12 months of a second TearCare(®) treatment on subjects with dry eye disease

PURPOSE: Evaluation of the safety and effectiveness of a TearCare(®) retreatment in adult subjects with clinically significant dry eye disease (DED). PATIENTS AND METHODS: This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study. In the initial study, subjects with DED were randomized to either a single TearCare(®) treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare(®) treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare(®) retreatment for another 6 months through a 12-month end point. The TearCare(®) retreatment procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual meibomian gland clearance. The primary effectiveness end point was the change in tear break-up time (TBUT) from baseline to 1-month follow-up. Secondary end points included meibomian gland scores, corneal and conjunctival staining scores, and assessment of dry eye symptoms. Safety was evaluated through monitoring intraocular pressure, best-corrected visual acuity, and device-related adverse events. RESULTS: Twelve subjects participated in the 6-month extension study. At 1-month clinic visit following retreatment, a significant improvement from baseline in mean (± SD) TBUT of 12.4 (±3.3) seconds was observed (P<0.001). Significant improvements in the mean change from baseline in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of DED were also observed following retreatment. The second treatment was well tolerated. CONCLUSION: The findings of the extension study through 12 months suggest that a second TearCare(®) treatment after 6 months provides additional improvement in the signs and symptoms of DED.