Safety and Efficacy of Moxifloxacin-Dexamethasone Eyedrops as Treatment for Bacterial Ocular Infection Associated with Bacterial Blepharitis

Safety and Efficacy of Moxifloxacin-Dexamethasone Eyedrops as Treatment for Bacterial Ocular Infection Associated with Bacterial Blepharitis

Author Belfort, Rubens Autor UNIFESP Google Scholar
Gabriel, Luis Autor UNIFESP Google Scholar
Martins Bispo, Paulo Jose Autor UNIFESP Google Scholar
Muccioli, Cristina Autor UNIFESP Google Scholar
Zacharias Serapicos, Patricia Cabral Autor UNIFESP Google Scholar
Clark, Linda Google Scholar
Bell, Belinda Google Scholar
Bartell, John Google Scholar
Stroman, David W. Google Scholar
Hoefling-Lima, Ana Luisa Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Alcon Res Ltd
Abstract Treatments that offer two medications in a fixed combination have the potential to offer efficacious and safe treatment with advantages such as a regimen that is simpler than administering two separate solutions. This study evaluated the safety and efficacy of fixed-combination versus concomitant moxifloxacin 0.5% and dexamethasone 0.1% ocular solutions for the treatment of bacterial ocular inflammation and infection.The clinical study design was a randomized, double-masked, active-controlled, parallel-group trial of 102 subjects with bacterial blepharitis in which two patients also had bacterial conjunctivitis. All subjects received two bottles of study medication: either a fixed combination of moxifloxacin 0.5%/dexamethasone 0.1% ophthalmic solution and placebo eye drops (fixed-dose group), or moxifloxacin 0.5% ophthalmic solution and dexamethasone 0.1% (concomitant group). One drop of each study medication was instilled bilaterally four times per day for 7 days. Clinical resolution, signs, symptoms, and safety were assessed. Microbiological specimens were collected from the eyelid margin and conjunctivae of each eye from each patient at the time of enrollment and at the exit visit.Clinical resolution occurred similarly in both groups (81.6% of eyes, fixed-dose group; 82.3% of eyes, concomitant group). Moreover, the microbiological efficacy of the treatment was also similar for both the fixed-dose group (84%) and the concomitant group (83%). Ocular symptoms and signs improved over time, with no significant differences between groups after 7 days of treatment, except the fixed-dose group had significantly more eyes with clinical resolution in eyelid erythema (100%, n = 98/98, fixed-dose group; 92.7%, n = 89/96, concomitant group; P = 0.0194) and eyelid scaling/crusting (98%, n = 96/98, fixed-dose group; 89.6%; n = 86/96 eyes, concomitant group; P = 0.0337). Both regimens were safe and well tolerated.The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.
Keywords Blepharitis
Language English
Sponsor Alcon Laboratories, Inc.
Date 2012-05-01
Published in Advances in Therapy. New York: Springer, v. 29, n. 5, p. 416-426, 2012.
ISSN 0741-238X (Sherpa/Romeo, impact factor)
Publisher Springer
Extent 416-426
Access rights Closed access
Type Article
Web of Science ID WOS:000305225900003

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