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Kamran Hosseini, Judith Hutcheson, Lyle M. Bowman; Clinical Response of Dexamethasone 0.1% Formulated in DuraSite on Blepharoconjunctivitis Patients. Invest. Ophthalmol. Vis. Sci. 2011;52(14):4247.
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To study the efficacy and safety of 0.1% Dexamethasone in DuraSite at b.i.d. dosing for patients with signs & symptoms of blepharoconjunctivitis.
As a part of a Phase III study, 136 male and female subjects with signs & symptoms of blepharoconjunctivitis were treated with Dexamethasone 0.1% in DuraSite at b.i.d. dosing for 14 days. The average age was 60.63, for 58 males (42.6%) and 78 females (57.4%). In total, 126 patients completed the study.
Clinical resolution was defined as the absence of all clinical signs and symptoms. The "intent-to-treat" (ITT) population with "last observation carried forward" (LOCF) data was used in the analyses for the last visit clinical resolution. 23.5% of the patients showed clinical resolution from all signs and symptoms of blepharoconjunctivitis. Another efficacy endpoint was bacterial eradication of baseline bacterial species at last clinical visit. Eradication was assessed for the conjunctiva and lid separately as well as combined. The "modified intent-to-treat" (mITT) population with LOCF data was used in these analyses for last visit clinical resolution. 40.2% of the patients showed bacterial eradication for the conjunctiva and eyelids combined. 40.9% showed bacterial eradications for eyelids only, and 64.3% showed bacterial eradication for conjunctiva only. There were no major adverse events recorded for this study. 4 patients showed elevated intraocular pressure (IOP) of which only 1 had to discontinue the study.
Ocular instillation of DuraSite eye drop formulation with Dexamethasone 0.1% at b.i.d. for 14 days proves a safe and efficacious therapy for blepharoconjunctivitis. The bacterial eradication that resulted could be (at least partially) attributed to the benzalkonium chloride (BAK) present in the formulation (0.003%).
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