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Serge Doan, Christophe Baudouin, Marc Labetoulle, Tristan Bourcier, Louis Hoffart, Pierre-Jean Pisella, ; Efficacy and Safety of azithromycin 1.5% eye drops (Azyter®) in patients with moderate to severe chronic blepharitis.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):47.
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To compare the efficacy and safety of azithromycin 1.5% (Azyter®) and placebo eye drops in patients suffering from chronic moderate-to-severe anterior and/or posterior blepharitis.
This prospective, multicenter, randomized, double-masked, parallel group, phase II pilot study was conducted in 93 chronic blepharitis patients. After a 2-week wash-out period with daily eyelid care, patients with resistant moderate-to-severe blepharitis randomly received azithromycin (AZM) 1.5% or placebo (polyvidone) eye drops for 7 days (2 drops on D1, then one drop daily), followed by a 2-week treatment-free period. This therapeutic scheme was repeated twice. The primary endpoint was the change from D0 to D63 in global ocular discomfort assessed on a 100-mm visual analogue scale (VAS). Secondary outcomes included the evaluation of ocular symptoms (irritation, itching, crusting, sticking, light sensitivity, blinking) and signs (margin redness, eyelid swelling, meibomian gland (MG) dysfunction and quality of MG secretions; semi-qualitative VAS).
Mean ocular discomfort reduction (D0 to D63) was -33.9 ± 20.2 mm (-52.2%) on AZM and -26.1 ± 24.0 mm (-41.1%) on placebo in the Full Analysis Set (FAS). Using a mixed model for repeated measures, the estimated mean differences between treatments (AZM - placebo) in discomfort score was -8.01 mm in the FAS and -10.37 mm in the Per Protocol (PP) Set on D63. The between-group difference was close to statistical significance in the FAS (p=0.072), and statistical significant in the PP Set (p=0.026). AZM-treated patients also had a lower total symptom score (vs. placebo-treated patients; p=0.005) and a lower VAS score for blepharitis signs (p=0.092) on D63. Both treatments were well tolerated.
Azithromycin 1.5% eye drops were effective and safe for the management of moderate-to-severe blepharitis. They appear as a promising therapeutic option, with notably additional anti-inflammatory activities over the standard eyelid care.
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