Evaluation of the Efficacy and Safety of a Fixed Combination of Azithromycin and Dexamethasone and of Dexamethasone Alone in Drug Delivery System in the Treatment of Blepharitis: Phase 3 Clinical Study
Purpose
To evaluate the efficacy and safety of the combination and single agents, dexamethasone and azithromycin in DuraSite vehicle (AzaSite). The study was also designed to investigate disease response to therapy in combination with lid hygiene using lid scrubs. Furthermore, the recurrence rate of the disease was to be investigated during a 6 month follow up period.
Methods
In this randomized, double masked, multicenter, 4-arm, parallel-group, comparative study subjects received: dexamethasone-azithromycin combination (n=305), dexamethasone (n=298), AzaSite (n=155), or DuraSite Vehicle (n=149). Subjects started the study with a weeklong lid hygiene regimen followed by the application of 1 drop of study medication onto the eyelid(s) twice a day for 14 days. Subjects were assessed on Day 4 during the 2-week dosing period, and at day 15 and Month 1, 2, 3, 4, 5, and 6 during the 6 month post-treatment evaluation phase.. The clinical signs (eyelid redness, eyelid swelling, lid-debris) and eyelid irritation were evaluated. Furthermore, a Patient Report Outcome instrument designed in collaboration with UCLA and FDA was employed to assess the patient’s satisfaction level during the study.
Results
Subjects randomized to the dexamethasone-azithromycin combination arm and dexamethasone arm had a statistically significantly (p < 0.05) greater reduction in blepharitis scores when compared to AzaSite and/or Vehicle arms. The proportion of subjects with the eyelid irritation score of 0 at Day 15 were significantly (p < 0.05) higher in those dexamethasone containing arms as well. Adverse events were reported in approximately 26% of the patients, with an equal distribution among the corticosteroid containing and Vehicle arms, with approximately 21% in the AzaSite arm. Intraocular pressure increase was observed in the combination (2%), dexamethasone alone (1%), and AzaSite (1.3%) arms.
Conclusion
The potent anti-inflammatory properties of dexamethasone formulated in the long lasting DuraSite vehicle appear to be efficacious in treating these important signs and symptoms of blepharitis, which was maintained for up to 6 months for a vast majority of the patients. Additionally, no significant safety findings were reported.