title: Comparison of ciprofloxacin ophthalmic solution 0.3% to fortified tobramycin-cefazolin in treating bacterial corneal ulcers. Ciprofloxacin Bacterial Keratitis Study Group.
abstract: OBJECTIVE
  The purpose of the study is to compare the clinical efficacy and safety of ciprofloxacin ophthalmic solution 0.3% (Ciloxan) with a standard therapy regimen (fortified tobramycin, 1.3%-cefazolin, 5.0%) for treating bacterial corneal ulcers.
  
  
  METHODS
  This randomized, parallel group, double-masked, multicenter study was conducted in 324 patients at 28 centers in the United States, Europe, and India. Patients were randomized into 2 treatment groups: 160 to ciprofloxacin and 164 to fortified tobramycin-cefazolin. Positive microbiologic cultures were obtained in 188 (58%) of 324 patients. Of these, 176 patients met protocol criteria and were evaluated for treatment efficacy: 82 in the ciprofloxacin group and 94 in the standard therapy group. The dosing schedule for both treatment groups was 1 to 2 drops of the first study medication (ciprofloxacin or fortified tobramycin) every 30 minutes for 6 hours, then hourly for the remainder of day 1; 1 to 2 drops every hour on days 2 and 3; 1 to 2 drops every 2 hours on days 4 and 5, followed by 1 to 2 drops every 4 hours on days 6 to 14. The second medication (ciprofloxacin or cefazolin) was instilled 5 to 15 minutes after the first drug, following the same dosing frequency. Physician's judgment of clinical success, cure rate, changes in ocular sings, and symptoms and the rate of treatment failures were the primary efficacy criteria.
  
  
  RESULTS
  Topical ciprofloxacin monotherapy is equivalent clinically and statistically to the standard therapy regimen of fortified antibiotics. No statistically significant treatment differences were found between ciprofloxacin (91.5%) and standard therapy (86.2%) in terms of overall clinical efficacy (P = 0.34). Similarly, no differences were noted in resolution of the clinical signs and symptoms (P > 0.08) or the time to cure (P = 0.55). The incidence of treatment failures was less in the ciprofloxacin group (8.5%) compared with the standard therapy group (13.8%). Significantly fewer patients treated with ciprofloxacin reported discomfort than did patients treated with the standard therapy regimen (P = 0.01).
  
  
  CONCLUSIONS
  Ciprofloxacin ophthalmic solution 0.3% monotherapy is equivalent clinically and statistically to standard therapy (fortified tobramycin-cefazolin) for the treatment of bacterial corneal ulcers and produces significantly less discomfort.
authors.affiliation: Medical College of Wisconsin, Milwaukee, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Hyndiuk
authors.forename: R A
authors.initials: RA
authors.lastname: Eiferman
authors.forename: D R
authors.initials: DR
authors.lastname: Caldwell
authors.forename: G O
authors.initials: GO
authors.lastname: Rosenwasser
authors.forename: C I
authors.initials: CI
authors.lastname: Santos
authors.forename: H R
authors.initials: HR
authors.lastname: Katz
authors.forename: S S
authors.initials: SS
authors.lastname: Badrinath
authors.forename: M K
authors.initials: MK
authors.lastname: Reddy
authors.forename: J P
authors.initials: JP
authors.lastname: Adenis
authors.forename: V
authors.initials: V
authors.lastname: Klauss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D002437:Cefazolin / Q000009:adverse effects / Q000627:therapeutic use*; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002939:Ciprofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D003315:Cornea / Q000382:microbiology; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D014031:Tobramycin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D002511:Cephalosporins; D009883:Ophthalmic Solutions; D002939:Ciprofloxacin; D002437:Cefazolin; D014031:Tobramycin