Fluoroquinolones are antibiotics used for treating certain types of bacterial infections. These drugs are FDA approved to be taken systemically. However, some phase IV (post-approval)
Fluoroquinolones are antibiotics used for treating certain types of bacterial infections. These drugs are FDA approved to be taken systemically. However, some phase IV (post-approval) studies have shown that use of these drugs can be a risk factor for the development of peripheral neuropathy (i.e., neurologic symptoms), and the safety labeling has been changed accordingly. A small clinical trial was set up to study the safety and effectiveness of two ophthalmic solutions (i.e., eye drops) in this drug class that are intended to be used to treat bacterial ocular infections. Two active drugs in this class (drug M and drug G) together with a placebo (drug P) were studied according to the following design. Ninety three normal subjects were randomized to one of three groups in approximately equal numbers, as shown in Table 12.50. Thus, for each subject in group A, drug G was administered to a randomly selected eye and drug P to the fellow eye. Groups B and C are defined similarly. Each person was told to administer the two assigned drugs four times per day for 10 days. The principal outcome (or response) measure in the study was corneal sensitivity, measured in millimeters, which has values in the range of 4060 mm. gh values of corneal sensitivity indicate greater sensitivity (i.e., normal), whereas low values indicate poor sensitivity (i.e., abnormal). Corneal sensitivity was measured at baseline, at 7 days, and at 14 days. Note that each person was still taking study drug at day 7 but not at day 14. Table 12.50: Treatment assignments in ocular infection clinical trial
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