COMPARISON OF CIPROFLOXACIN OPHTHALMIC SOLUTION 0.3-PERCENT TO FORTIFIED TOBRAMYCIN-CEFAZOLIN IN TREATING BACTERIAL CORNEAL ULCERS

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, paral lel group, double-masked, multicenter study was conducted in 324 patie nts at 28 centers in the United States, Europe, and India. Patients we re 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 prot ocol criteria and were evaluated for treatment efficacy: 82 in the cip rofloxacin group and 94 in the standard therapy group. The dosing sche dule for both treatment groups was 1 to 2 drops of the first study med ication (ciprofloxacin or fortified tobramycin) every 30 minutes for 6 hours, then hourly for the remainder of day 1, 1 to 2 drops every hou r on days 2 and 3; 1 to 2 drops every 2 hours on days 4 and 5, followe d 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 signs, and symptoms and the rate of treatment failures were the primary efficacy criteria. Results: Topical ciprofloxacin monotherapy is equivalent clinically a nd statistically to the standard therapy regimen of fortified antibiot ics. No statistically significant treatment differences were found bet ween ciprofloxacin (91.5%) and standard therapy (86.2%) in terms of ov erall clinical efficacy (P = 0.34). Similarly, no differences were not ed 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 g roup (13.8%). Significantly fewer patients treated with ciprofloxacin reported discomfort than did patients treated with the standard therap y 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 bacteria l corneal ulcers and produces significantly less discomfort.