Comparison of ciprofloxacin ophthalmic solution 0.3% to fortified tobramycin-cefazolin in treating bacterial corneal ulcers. Ciprofloxacin Bacterial Keratitis Study Group

Ophthalmology. 1996 Nov;103(11):1854-62; discussion 1862-3. doi: 10.1016/s0161-6420(96)30416-8.

Abstract

Purpose: 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).

Conclusion: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use*
  • Bacteria / isolation & purification
  • Cefazolin / adverse effects
  • Cefazolin / therapeutic use*
  • Cephalosporins / adverse effects
  • Cephalosporins / therapeutic use*
  • Child
  • Ciprofloxacin / adverse effects
  • Ciprofloxacin / therapeutic use*
  • Cornea / microbiology
  • Corneal Ulcer / drug therapy*
  • Corneal Ulcer / microbiology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Eye Infections, Bacterial / drug therapy*
  • Eye Infections, Bacterial / etiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Prospective Studies
  • Tobramycin / adverse effects
  • Tobramycin / therapeutic use*

Substances

  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Cephalosporins
  • Ophthalmic Solutions
  • Ciprofloxacin
  • Cefazolin
  • Tobramycin