Efficacy and Safety of Wet Wipes Containing Hy-Ter® Solution Compared with Standard Care for Bilateral Posterior Blepharitis: A Preliminary Randomized Controlled Study

Abstract

Introduction: A novel treatment for posterior blepharitis which involves the use of disposable wet wipes imbibed with a solution of terpinen-4-ol and hyaluronic acid (Hy-Ter®) as well as aloe, natural anti-inflammatories and antiseptics (Blephapad Combo; Novelty Technology Care, Milan, Italy) has been proposed. The aim of this study was to compare the efficacy and safety of treatment with Blephapad Combo with standard treatment.

Methods: We conducted 4-week, open-label, randomized controlled study with a closed sequential design at the Magna Graecia University of Catanzaro, Italy in which patients aged > 40 years with symmetrical bilateral posterior blepharitis were enrolled. Each eye represented a single experimental unit. Patients were randomly assigned using a computer-generated randomization list to apply a reusable heated compress to the eyelid of one eye before cleansing the eyelid with the Blephapad Combo wet wipe (Blephapad Combo treatment arm) or to use the standard treatment of applying a wet and warm gauze to the other eye (standard treatment arm), twice daily for 4 weeks. The primary endpoint was the percentage change from baseline to week 4 in meibomian gland dysfunction (MGD) grading scale scores.

Results: Eighteen patients (9 men; 9 women) with a mean (± standard deviation) age of 66.9 ± 9.03 years were included in the study. Compared with the eye receiving the standard treatment, treatment with Blephapad Combo appeared to improve the MGD total score after 4 weeks of treatment (mean change from baseline - 29.9 vs. - 38.5%). The assessment of the investigators was that in 11 patients the eye treated with Blephapad Combo showed greater benefit, in two patients the eye treated with the standard treatment showed greater benefit and in four patients there was no difference between treatments. Blephapad Combo was well tolerated, with no serious adverse events (AEs) reported. Minor ocular AEs were reported in 44.4 and 38.9% of patients in the Blephard Combo and standard treatment arms, respectively.

Conclusions: Treatment with Blephapad Combo was more effective than the standard treatment in ameliorating MGD in patients with posterior blepharitis. Minor ocular AEs events were equally distributed between the two treatments arms.

Trial registration: ClinicalTrials.gov identifier: NCT03301844.

Keywords: Blephapad Combo; Blepharitis; Keratoconjunctivitis sicca; Meibomian gland; Randomized controlled trial.

Figures

Fig. 1

Closed sequential design diagram

Fig. 2

At the biomicroscopic examination conducted during the pre-treatment stage (upper- and lower-left images), the conjunctiva is hyperemic, especially in the interpalpebral area; there are specific opacities on the corneal surface in the lower area, referred to as superficial punctate keratitis (upper left). The image reveals orifice plugs protruding from the lid margin (lower left). After treatment (upper- and lower-right images), the biomicroscopic examination revealed a reduction in hyperemia, a complete resolution of the punctate keratitis (upper right) and an improvement in meibomian gland orifice plugging (lower right)