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Kamran Hosseini, Judith A Hutcheson, Lyle M Bowman; Clinical Response to Treatment with Topical Ocular 0.1% Dexamethasone in DuraSite® in Subjects with Blepharitis. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1459.
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To evaluate the efficacy and safety of topical ocular twice daily (BID) administration of 0.1% dexamethasone formulated in DuraSite®, in subjects with signs and symptoms of blepharitis. Dexamethasone is a potent corticosteroid commonly prescribed as an ocular anti-inflammatory agent, and DuraSite® is a topical ocular drug delivery formulation that facilitates ocular surface retention time of ophthalmic medications.
As part of a Phase 3 study, this was a prospective, randomized, double-masked clinical trial. Subjects with signs and symptoms of blepharitis were treated for 14 days. The following 3 signs and 1 symptom were used to evaluate the severity of blepharitis: eyelid redness, eyelid swelling, eyelid debris, and eyelid irritation, on a 0 to 3 scale (0, absent and 3, severe). The investigator also rated global efficacy on a 0 to 3 scale (0, cured and 3, worsened).
Overall, 298 subjects received at least 1 dose of study drug, and 187 (62.8%) completed the study through Day 15 (post 14 days of BID dosing). The proportions of male and female subjects were similar, 47.0% and 53.0%, respectively. Average subject age was 60.8 years (range, 18 to 91). Primary efficacy, assessed as complete resolution of blepharitis signs and symptoms at Day 15 (‘0’ rating for all signs/symptoms) was observed in 5.7% (17/298) of subjects. Subjects who had a decrease from baseline in all signs/symptoms of 75%, 50%, and 25% (concurrent with at least a 1 unit decrease in redness and irritation) at Day 15 were also summarized: 17.1% (51/298) improved by 75%, 40.9% (122/298) improved by 50%, and 49.3% (147/298) improved by 25%. The majority of subjects were also rated as improved (85.4%, 251/298) on the investigator’s global assessment at Day 15. One subject (0.3%) experienced an IOP increase from 9 mm/Hg at baseline to 19 mm/Hg on Day 15, but returned to 16 mm/Hg when subject exited a month later. Two subjects (0.6%) showed IOP values > 22 mm/Hg at the end of the dosing period (Day 15). Only 7 (2.3%) subjects terminated the study early due to an AE and no serious or severe AEs were reported during the study.
Topical ocular BID administration of 0.1% dexamethasone in DuraSite for 14 days was safe and was associated with clinical improvement in blepharitis signs & symptoms.
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