5% ophthalmic solution were excluded. Patients were recruited from more than 800 medical facilities in Japan, and treatment was based on the decision of the physician. The study protocol was set up in accordance with Ministry of Health, Labour and Welfare ordinance guidelines,[10,11] and a contract with all medical facilities participating selleck chemicals in this study was constructed. Written informed

consent was not obtained, as Japanese law does not require informed consent for this type of non-interventional observational study. Study Design To eliminate bias in case extraction, a continuous investigation method was adopted, where patients were registered in chronological order depending on the time when treatment was initiated. Of these patients, those re-visiting NCT-501 mw the same medical facility were formally enrolled in the survey in chronological order (depending on the date of the first treatment with levofloxacin 0.5% ophthalmic solution) and entered into the case report form (CRF). The end of enrollment at each medical facility occurred at the time when the number of patients reached the number specified in that

facility’s contract. The influence of the development of drug-resistant bacterial strains on the efficacy of levofloxacin over time was also investigated, by conducting the survey in three distinct time periods: from April 2000 through to December 2001 (the first period), from January

2002 through to June 2003 (the second period), and from July 2003 through to December 2004 (the third period). The targeted number of patients was 2000 for each time period. Survey Design and Analysis Survey Items The survey collected data pertaining to the background characteristics and demographics of each patient, the dosage and treatment duration of levofloxacin 0.5% ophthalmic solution, concomitant drugs and therapies, Ilomastat Clinical symptoms of infection, adverse events associated with treatment, before overall improvement, and bacteriological test data (if assessed). Safety Adverse events were defined as any medically unfavorable event taking place during or after treatment with levofloxacin 0.5% ophthalmic solution. Adverse drug reactions (ADRs) were considered treatment related if a causal relationship with levofloxacin 0.5% ophthalmic solution could not be ruled out. Efficacy The efficacy of levofloxacin 0.5% ophthalmic solution was assessed by the physicians in charge of each medical center, using a three-category scale. The overall change was rated as ‘improved’, ‘unchanged’, or ‘worsened’. Clinical response rates were assessed, using the following calculation: $$\rmResponse\;rate(\% ) = {\rmNo\rm.\;of\;improved\;patients \over {\rmTotal\;no{\rm{.