Purpose: To evaluate the efficacy and safety of eyelid hygiene using topical 0.01% hypochlorous acid (HOCL) through ultrasonic atomization after 2 weeks in patients with blepharitis.
Design: Randomized controlled trial.
Methods: Patients with blepharitis were randomized into two groups: topical 0.01% HOCL through ultrasonic atomization (HOCL group, 42 eyes) or eyelid scrubs (control group, 37 eyes). Patients in both groups received warm compresses twice daily and topical 0.5% levofloxacin three times a day. Primary outcomes were the ocular surface disease index scores (OSDI), lid margin redness, lid margin abnormalities, meibum expressibility, meibum quality, and noninvasive breakup time after 2 weeks. Secondary outcomes were conjunctiva redness, corneal fluorescein staining, and tear meniscus height. A questionnaire of treatment adherence with a free response section was administered to confirm patient compliance and comments.
Results: Sixty-seven participants participated in this study. Both groups show an improvement in all primary outcomes, while statistically significant improvements in OSDI, lid margin redness, lid margin abnormality, meibum expressibility and quality are only limited to the HOCL group after 2 weeks of treatment (p < 0.05, p < 0.05, p < 0.001, p < 0.001 and p < 0.001, respectively). Subgroup analysis in HOCL reveals that only the change in lid margin abnormality and meibum expressibility in the mild-moderate meibomian glands loss patients at baseline has a statistically significant difference p < 0.05). Multiple linear regression shows that the improvement in OSDI is negatively associated with meibum expressibility score at the baseline (95% CI [-28.846, -1.815], p = 0.028). The patient compliance is 7.1 ± 2.0 in the HOCL group and 7.1 ± 1.8 in the control group (p > 0.05). No adverse events are reported.
Conclusion: Topical 0.01% HOCL through ultrasonic atomization is a tolerable and effective eyelid hygiene treatment for blepharitis.
Keywords: blepharitis; dry eye; hypochlorous acid (HOCL); meibomian gland dysfunction; ultrasonic atomization.