title: Evaluation of moxifloxacin 0.5% in treatment of nonperforated bacterial corneal ulcers: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the equivalence of moxifloxacin 0.5% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of moderate bacterial corneal ulcers.
  
  
  METHODS
  Randomized, controlled, equivalence clinical trial.
  
  
  METHODS
  Microbiologically proven cases of bacterial corneal ulcers were enrolled in the study and were allocated randomly to 1 of the 2 treatment groups.
  
  
  METHODS
  Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate) and group B was given monotherapy (moxifloxacin 0.5%).
  
  
  METHODS
  The primary outcome variable for the study was percentage of the ulcers healed at 3 months. The secondary outcome variables were best-corrected visual acuity and resolution of infiltrates.
  
  
  RESULTS
  Of a total of 224 patients with bacterial keratitis, 114 patients were randomized to group A, whereas 110 patients were randomized to group B. The mean ± standard deviation ulcer size in groups A and B were 4.2 ± 2 and 4.41 ± 1.5 mm, respectively. The prevalence of coagulase-negative Staphylococcus (40.9% in group A and 48.2% in group B) was similar in both the study groups. A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8%) in group A and 88 patients (81.4%) in group B at 3 months. The observed percentage of healing at 3 months was less than the equivalence margin of 20%. Worsening of ulcer was seen in 18.2% cases in group A and in 18.5% cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P = 0.065). No serious events attributable to therapy were reported.
  
  
  CONCLUSIONS
  Corneal healing using 0.5% moxifloxacin monotherapy is equivalent to that of combination therapy using fortified cefazolin and tobramycin in the treatment of moderate bacterial corneal ulcers.
  
  
  BACKGROUND
  The author(s) have no proprietary or commercial interest in any materials discussed in this article.
authors: Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. namrata.sharma@gmail.com
authors: Namrata
authors: N
authors: Sharma
authors: Manik
authors: M
authors: Goel
authors: Shubha
authors: S
authors: Bansal
authors: Prakashchand
authors: P
authors: Agarwal
authors: Jeewan S
authors: JS
authors: Titiyal
authors: Ashish D
authors: AD
authors: Upadhyaya
authors: Rasik B
authors: RB
authors: Vajpayee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D002437:Cefazolin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003315:Cornea / Q000187:drug effects / Q000503:physiopathology; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions; D015995:Prevalence; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013810:Therapeutic Equivalency; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects / Q000502:physiology
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D011804:Quinolines; D002437:Cefazolin; D000077266:Moxifloxacin; D014031:Tobramycin