title: Safety and efficacy of moxifloxacin-dexamethasone eyedrops as treatment for bacterial ocular infection associated with bacterial blepharitis.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.
authors.affiliation: Vision Institute, Federal University of São Paulo, Rua Botucatu 822, 04023-062, São Paulo, Brazil. clinbelf@uol.com.br
authors.forename: Rubens
authors.initials: R
authors.lastname: Belfort
authors.forename: Luis
authors.initials: L
authors.lastname: Gabriel
authors.forename: Paulo José
authors.initials: PJ
authors.lastname: Martins Bispo
authors.forename: Cristina
authors.initials: C
authors.lastname: Muccioli
authors.forename: Patricia Cabral
authors.initials: PC
authors.lastname: Zacharias Serapicos
authors.forename: Linda
authors.initials: L
authors.lastname: Clark
authors.forename: Belinda
authors.initials: B
authors.lastname: Bell
authors.forename: John
authors.initials: J
authors.lastname: Bartell
authors.forename: David W
authors.initials: DW
authors.lastname: Stroman
authors.forename: Ana Luisa
authors.initials: AL
authors.lastname: Höfling-Lima
mesh_terms: D060433:Administration, Ophthalmic; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001762:Blepharitis / Q000188:drug therapy* / Q000382:microbiology; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D004338:Drug Combinations; D024841:Fluoroquinolones; D005938:Glucocorticoids; D011804:Quinolines; D003907:Dexamethasone; D000077266:Moxifloxacin