February 01, 1996
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Ofloxacin found as effective as antibiotic combination to treat bacterial keratitis

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BALTIMORE—A recently completed prospective, multicenter trial confirms that a fluoroquinolone, Ocuflox (ofloxacin, Allergan) is as effective in treating bacterial keratitis as is the standard fortified antibiotic treatment consisting of cefazolin and tobramycin, according to Terrence P. O'Brien, MD, principal investigator of the bacterial keratitis study group and director of ocular microbiology at the Wilmer Eye Institute at Johns Hopkins University located here.

"There was no definitive treatment trial to assess optimal therapy for bacterial keratitis until we organized this multicenter randomized, comparative trial," O'Brien said.

The study included 28 different clinical and academic centers and 140 patients who were culture positive for bacteria causing keratitis.

The efficacy of ofloxacin solution in treating bacterial keratitis was found to be equivalent to that of the fortified cefazolin and tobramycin solutions. The reduced frequency of ocular toxic effects and the relative ease of preparation of ofloxacin are additional considerations.

One drug is easier

"The advantage of having one drug is that it is easier for the patient to get it in his or her eyes than trying to do two drops," said Francis W. Price Jr., MD, in private practice in Indianapolis. "And some of the drops that we would mix up were irritating to the eye. These are not."

Currently only one drug, Ciloxan (ciprofloxacin HCl, Alcon), has Food and Drug Administration (FDA) approval for treating bacterial keratitis, O'Brien said, adding that Ocuflox is pending approval by the FDA for bacterial keratitis. Both drugs have been available for about 5 years, and both are approved for treating conjunctivitis.

New for treating eye infections

"The fluoroquinolones are a whole new generation of drugs, especially with regard to treating eye infections. They are more broad spectrum than anything we have had before," said Price.

They have good penetration and are good as preand postoperative prophylactics, especially Ocuflox, he said.

"In a non-inflamed eye, it penetrates the epithelium, gets into the deep tissues of the cornea and even into the deeper areas of the eye such as the anterior chamber," Price said. Fluoroquinolones can also be used systemically to treat endophthalmitis.

"I think a number of us would use these drugs in their oral form to treat endophthalmitis because they have good penetration. Recently, some studies have indicated that giving patients IV antibiotics is not needed for endophthalmitis," he said.

Monitor bacterial resistance

Bacterial resistance to fluoroquinolones, however, is starting to appear both with systemic use of the drugs and to a lesser extent with topical use in the eye. "It is something we have to monitor carefully," Price said.

Moreover, some bacteria are inherently resistant to the fluoroquinolones, O'Brien noted. "These include streptococci, enterococci, non-aeruginosa Pseudomonas and anaerobic species," he said.

Older, more traditional drugs, such as penicillin and aminoglycosides can be used in these cases.

Neither Price nor O'Brien has a financial interest in the firms manufacturing these drugs.