Comparison of Efficacy and Safety of Two Tea Tree Oil-Based Formulations in Patients with Chronic Blepharitis: A Double-Blinded Randomized Clinical Trial.

Introduction: It was aimed to evaluate the efficacy of two tea tree oil (TTO)-based cleansing gels in chronic blepharitis patients. Methods: Group-1 (basic gel containing 3%(w/w)-TTO) included 50 eyes of 25 patients and group-2 (advanced gel containing 3%(w/w)-TTO plus essential oils and vitamins) included 48 eyes of 24 patients. Ocular Surface Disease Index (OSDI), tear breakup time (TBUT), ocular surface staining pattern, Schirmer's test, impression cytology, Demodex presence and TNF-alpha, IL-6, IL-1 beta levels were evaluated at the first visit and 1 month after treatment. Results: In both groups, the mean OSDI score decreased (p1:0.001, p2:0.001), TBUT increased (p1:0.002, p2:0.004). In group-1, Demodex presence decreased from 42% to 27.8%; in group-2 from 54.2% to 20.6% (p1:0.302, p2:0.004). IL-1 beta and IL-6 decreased in group-2 (p1:0.002, p2:0.050). TNF-alpha decreased in both groups (p1:0.001, p2:0.001). Conclusion: Both formulations improved ocular surface parameters. Group 2 showed more reduction in tear cytokines and Demodex count.