RESUMEN
Demodex represents the most frequent ectoparasite found in humans. Although Demodex mites are considered commensals of human pilosebaceous units, an abnormally high mite density can cause several ocular and cutaneous symptoms and signs, sometimes to a severe degree. Both Demodex spp. (folliculorum and brevis) play a significant part in eye pathology and facial dermatoses. These mites have been related to blepharitis, ocular rosacea, meibomian gland dysfunction and various skin diseases, including rosacea, demodicosis and seborrheic dermatitis. Understanding the importance of Demodex in both eye and skin conditions is crucial for accurate diagnosis and appropriate management strategies, which may involve targeted treatments to control the mite population and reduce associated symptoms.
RESUMEN
PURPOSE: To evaluate the clinical efficacy and safety of a 1% azithromycin-0.1% dexamethasone combination in DuraSite ("combination") compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis. MATERIALS AND METHODS: This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1-6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety. RESULTS: A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the post-treatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug. CONCLUSION: A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated.