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.