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0.3% Ciprofloxacin Ophthalmic Ointment in the Treatment of Bacterial Keratitis
Kirk R. Wilhelmus, MD;
Robert A. Hyndiuk, MD;
Delmar R. Caldwell, MD;
Robert L. Abshire, PhD;
Alan T. Folkens, PhD;
Louis B. Godio, PhD;
Ciprofloxacin Ointment/Bacterial Keratitis Study Group
Arch Ophthalmol. 1993;111(9):1210-1218.
Abstract
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Objective
To determine the efficacy and safety of topical 0.3% ciprofloxacin hydrochloride ophthalmic ointment in the treatment of bacterial keratitis.
Design
Prospective case series with a nonrandomized comparison of culture-positive, evaluable cases (ciprofloxacin ointment group) with culture-positive, concurrent patients (nonenrolled group) treated with conventional therapy.
Setting
Multicenter clinical study.
Patients
After informed consent was obtained, 253 eligible patients underwent corneal scrapings and received topical ciprofloxacin ointment; 145 (57%) had positive cultures and completed the follow-up schedule. Forty (70%) of 57 apparently eligible patients had culture-positive bacterial keratitis but were not enrolled in the ciprofloxacin ointment study during the same period.
Intervention
Ciprofloxacin ophthalmic ointment instilled every 1 to 2 hours for 2 days, then every 4 hours for 12 days.
Main Outcome Measures
Clinical evaluation of signs at 1, 3, 7, and 14 days of treatment and the overall condition classified as clinical success (cured or improved) or failure (unchanged or worse) during and after therapy.
Results
Clinical success with the initial treatment occurred in 135 patients (93%) in the ciprofloxacin ointment group and in 28 patients (70%) in the nonenrolled group. Of the 10 ciprofloxacin clinical failures, seven were staphylococcal; two, pneumococcal; and one, polybacterial. The 90% minimum inhibitory concentration of ciprofloxacin was 3 mg/L or less for corneal bacterial isolates. No serious adverse event attributable to ciprofloxacin ointment occurred, although 32 (13%) of 253 patients developed a transient white crystalline corneal precipitate shown with liquid chromatography in two cases to be ciprofloxacin.
Conclusion
Ciprofloxacin ophthalmic ointment is an effective and safe topical antimicrobial agent for the treatment of bacterial keratitis caused by susceptible microorganisms.
Author Affiliations
From the Cullen Eye Institute, Baylor College of Medicine, Houston, Tex (Dr Wilhelmus); the Eye Institute, Medical College of Wisconsin, Milwaukee (Dr Hyndiuk); the Department of Ophthalmology, Tulane Medical Center, New Orleans, La (Dr Caldwell); and Alcon Laboratories Inc, Fort Worth, Tex (Drs Abshire, Folkens, and Godio). Drs Abshire, Folkens, and Godio are employees of Alcon Laboratories Inc. The other authors have no proprietary interest in this work.
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