OBJECTIVE: To evaluate the efficacy and safety of 0.3% lomefloxacin single agent solution, by comparing to a combination of fortified ophthalmic solutions of cefazolin sodium 50 mg/ml and gentamicin sulfate 14 mg/ml, in the treatment of acute bacterial keratitis. DESIGN: Prospective, double-masked, randomized comparative trial. METHOD:Forty patients with clinical diagnosis of any grade of severity of acute bacterial keratitis were randomized into 2 treatment groups: 20 to fortified cefazolin-gentamicin group, and 20 to lomefloxacin-normal saline group. The dosing of the drugs were scheduled for both treatment groups as follows: 1 drop of each solution was alternately instilled every 5 minutes for the first 30 minutes (as loading dose), then 1 drop with 5-minute interval between 2 bottles instilled hourly for day 1-3, tapering to every 2 hours on day 4-6, and every 4 hours on day 7-14. After day 14, dosing discretion was clinically adjusted, based on the clinical condition and finally discontinued after complete healing. Corneal scraping for cultures was obtained before starting the treatment. Ocular symptoms and signs, time to heal and adverse reactions were evaluated and compared between the 2 groups on day 2, 4, 7, 14, 21 and 28. RESULTS: No clinically or statistically significant difference were noted between two treatment groups, regarding demographic, symptoms and signs associated with bacterial keratitis. Positive results of bacterial corneal cultures were obtained in 27.5%. There was no statistically significant difference in time to complete re-epithelialization in all types of bacterial keratitis (P=0.251). By day 7, the keratitis was healed: 44% in lomefloxacin group, and 33% in fortified antibiotic group. Both study medications were well-tolerated, with no incidence of reported adverse event. CONCLUSION: In this study, eventhough there is no statistically significant difference of symptoms and signs between the two study groups at any study visit, we found clinical improvement in all patients in lomefloxacin group. So, lomefloxacin may be used as an alternative to standard treatment in acute bacterial keratitis.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of 0.3% lomefloxacin single agent solution, by comparing to a combination of fortified ophthalmic solutions of cefazolin sodium 50 mg/ml and gentamicin sulfate 14 mg/ml, in the treatment of acute bacterial keratitis. DESIGN: Prospective, double-masked, randomized comparative trial. METHOD: Forty patients with clinical diagnosis of any grade of severity of acute bacterial keratitis were randomized into 2 treatment groups: 20 to fortified cefazolin-gentamicin group, and 20 to lomefloxacin-normal saline group. The dosing of the drugs were scheduled for both treatment groups as follows: 1 drop of each solution was alternately instilled every 5 minutes for the first 30 minutes (as loading dose), then 1 drop with 5-minute interval between 2 bottles instilled hourly for day 1-3, tapering to every 2 hours on day 4-6, and every 4 hours on day 7-14. After day 14, dosing discretion was clinically adjusted, based on the clinical condition and finally discontinued after complete healing. Corneal scraping for cultures was obtained before starting the treatment. Ocular symptoms and signs, time to heal and adverse reactions were evaluated and compared between the 2 groups on day 2, 4, 7, 14, 21 and 28. RESULTS: No clinically or statistically significant difference were noted between two treatment groups, regarding demographic, symptoms and signs associated with bacterial keratitis. Positive results of bacterial corneal cultures were obtained in 27.5%. There was no statistically significant difference in time to complete re-epithelialization in all types of bacterial keratitis (P=0.251). By day 7, the keratitis was healed: 44% in lomefloxacin group, and 33% in fortified antibiotic group. Both study medications were well-tolerated, with no incidence of reported adverse event. CONCLUSION: In this study, eventhough there is no statistically significant difference of symptoms and signs between the two study groups at any study visit, we found clinical improvement in all patients in lomefloxacin group. So, lomefloxacin may be used as an alternative to standard treatment in acute bacterial keratitis.