Abstract
PURPOSE: This study evaluated the safety and effectiveness of TearCare(®) System to treat the signs and symptoms of dry eye disease (DED). METHODS: In this multicenter, prospective, post-market, exploratory, interventional trial, 58 eyes (29 subjects) received a single TearCare procedure and were assessed at baseline, post-procedure 1-week and 1-month. Effectiveness was assessed as mean change from baseline in tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), total Meibomian Gland Secretion Score (MGSS), and corneal/conjunctival staining. Adverse events (AE) and changes in visual acuity were used to asses safety. RESULTS: The baseline TBUT of 3.7±1.1 seconds was improved by 2.6±1.6 (70%) seconds at 1-week and by 3.1±2.2 (84%) seconds at 1-month (p < 0.0001). Mean baseline OSDI of 54.9±20.2 improved by 17.9±20.9 at 1-week and 25.8±24.3 at 1-month (p < 0.001). A clinically meaningful improvement was seen in 83% of subjects as per the Miller-Plugfelder definition and 66% of subjects improved by at least 1 OSDI category. The baseline MGSS of 5.6±4.0 improved by 9.3±4.0 at 1-week and 8.8±5.8 at 1-month (p < 0.0001). Corneal and conjunctival staining improved by 1.4±2.8 and 1.2±2.9 from a mean baseline of 4.8±2.5 and 5.9±3.2, respectively. Moreover, similar trajectories of improvement were observed for subgroups of subjects stratified by severity. Subjects with more severe gland obstruction at baseline had greater improvements in TBUT and staining compared to the less severe subgroup. No device-related adverse events or significant changes in visual acuity were observed. CONCLUSION: These results suggest that single TearCare procedure is safe and effective in treating signs/symptoms of DED. Significant improvements were seen in all subjects (100%) in all signs and symptoms of DED within 1-week of treatment and 83% subjects experienced clinically meaningful symptom relief. Additionally, TearCare seems to be effective in treating DED associated with all severities of meibomian gland obstruction.