Randomized double-blind trial of wipes containing terpinen-4-ol and hyaluronate versus baby shampoo in seborrheic blepharitis patients

Abstract

Purpose To investigate the efficacy of lid wipes (LWs) containing terpinen-4-ol and sodium hyaluronate (Hy-ter(R)) for the treatment of seborrheic blepharitis compared to baby shampoo (BS). Methods This randomized, double-blind, active control, parallel group, multicentre clinical trial included 48 eyes of 48 patients with seborrheic blepharitis who were randomly divided into two treatment arms (1:1, n = 24) using block randomization. LWs or BS were prescribed twice a day for 8 weeks followed by a discontinuation period of 4 weeks. Change in Blepharitis Symptom measure (BLISS), Schirmer's test, tear breakup time (TBUT), noninvasive TBUT (NI-TBUT), ocular surface disease index (OSDI) score, corneal and conjunctival staining, meibography, and Demodex count at different visits (Baseline, 4th, 8th, and 12th week) were the main outcome measures. Results The baseline values of both groups were similar (p > 0.05). Despite high clinical efficacy in both treatment arms, patients using LWs showed a lower BLISS score at the 8th and 12th-week visit (1.9 +/- 2.2 versus 7.2 +/- 6.6, p = 0.003; 4.0 +/- 1.3 versus 5.8 +/- 6.3, p = 0.026). NI-TBUT showed a significant increase starting from the 4th week for patients using LWs and 8th week for patients using BS. Both treatment modalities caused a reduction in the Demodex count after 4 weeks of treatment (p < 0.001). The treatment withdrawal did not cause any recurrence in both treatment arms. Conclusion BS or LWs containing Hy-ter(R) can be used with good efficacy for the treatment of seborrheic blepharitis. However, LWs may provide a better symptomatic relief compared to BS after 8 weeks of treatment.