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Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial.
Ophthalmology. 2007 Sep; 114(9):1622-9.O

Abstract

PURPOSE

To determine the clinical efficacy and safety of moxifloxacin (1.0%) in patients with bacterial keratitis compared with patients treated with ofloxacin (0.3%) or fortified tobramycin (1.33%)/cephazolin (5%).

DESIGN

Prospective randomized trial.

PARTICIPANTS

A total of 229 patients diagnosed with bacterial keratitis were enrolled in the study; 78 patients were randomized to the fortified tobramycin/cephazolin group, 77 patients to the moxifloxacin group, and 74 patients to the ofloxacin group. A total of 225 patients were evaluable for safety and 198 patients were included in the efficacy analysis.

INTERVENTION

After corneal specimens were obtained, the assigned study medication was instilled every hour, day and night, for 48 hours and on the third day, every hour by day and every 2 hours at night. For days 4 and 5, 1 drop every 2 hours by day and every 4 hours at night, and for days 6 and 7, 1 drop every 4 hours. After day 7, the antibiotic was tapered to every 6 hours and stopped when appropriate.

MAIN OUTCOME MEASURES

Resolution of keratitis and healing of ulcer, time to cure, mean time to discharge, clinical sign score, adverse reactions to study medication, and treatment failures.

RESULTS

Of the 186 nonexiting patients, resolution of the keratitis and healing of the ulcer occurred in 175 (94%) nonexiting patients. In the 175 patients in whom the corneal ulcer was cured, there were no statistically significant differences between the treatment groups for the mean time to cure (P = 0.25). There were no statistically significant differences between the 3 treatment groups in the various sign parameters including the sign score. A positive bacterial corneal culture was obtained in 190 (83%) of the 229 enrolled patients. The distribution of the species of bacterial organisms was similar in each treatment group and no significant difference in the percentage of isolates between the groups was observed. Twelve (5.2%) of the treated patients had serious complications (perforation or enucleation). No serious events attributable to therapy occurred during the study and all treatments were safe and well tolerated.

CONCLUSION

No difference in healing rate, cure rate, or complications between fortified cephazolin and tobramycin, ofloxacin, or moxifloxacin was seen in this study.

Authors+Show Affiliations

Corneal Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17822972

Citation

Constantinou, Marios, et al. "Clinical Efficacy of Moxifloxacin in the Treatment of Bacterial Keratitis: a Randomized Clinical Trial." Ophthalmology, vol. 114, no. 9, 2007, pp. 1622-9.
Constantinou M, Daniell M, Snibson GR, et al. Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. Ophthalmology. 2007;114(9):1622-9.
Constantinou, M., Daniell, M., Snibson, G. R., Vu, H. T., & Taylor, H. R. (2007). Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. Ophthalmology, 114(9), 1622-9.
Constantinou M, et al. Clinical Efficacy of Moxifloxacin in the Treatment of Bacterial Keratitis: a Randomized Clinical Trial. Ophthalmology. 2007;114(9):1622-9. PubMed PMID: 17822972.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. AU - Constantinou,Marios, AU - Daniell,Mark, AU - Snibson,Grant R, AU - Vu,Hien T, AU - Taylor,Hugh R, PY - 2006/02/13/received PY - 2006/12/03/revised PY - 2006/12/04/accepted PY - 2007/9/8/pubmed PY - 2007/9/19/medline PY - 2007/9/8/entrez SP - 1622 EP - 9 JF - Ophthalmology JO - Ophthalmology VL - 114 IS - 9 N2 - PURPOSE: To determine the clinical efficacy and safety of moxifloxacin (1.0%) in patients with bacterial keratitis compared with patients treated with ofloxacin (0.3%) or fortified tobramycin (1.33%)/cephazolin (5%). DESIGN: Prospective randomized trial. PARTICIPANTS: A total of 229 patients diagnosed with bacterial keratitis were enrolled in the study; 78 patients were randomized to the fortified tobramycin/cephazolin group, 77 patients to the moxifloxacin group, and 74 patients to the ofloxacin group. A total of 225 patients were evaluable for safety and 198 patients were included in the efficacy analysis. INTERVENTION: After corneal specimens were obtained, the assigned study medication was instilled every hour, day and night, for 48 hours and on the third day, every hour by day and every 2 hours at night. For days 4 and 5, 1 drop every 2 hours by day and every 4 hours at night, and for days 6 and 7, 1 drop every 4 hours. After day 7, the antibiotic was tapered to every 6 hours and stopped when appropriate. MAIN OUTCOME MEASURES: Resolution of keratitis and healing of ulcer, time to cure, mean time to discharge, clinical sign score, adverse reactions to study medication, and treatment failures. RESULTS: Of the 186 nonexiting patients, resolution of the keratitis and healing of the ulcer occurred in 175 (94%) nonexiting patients. In the 175 patients in whom the corneal ulcer was cured, there were no statistically significant differences between the treatment groups for the mean time to cure (P = 0.25). There were no statistically significant differences between the 3 treatment groups in the various sign parameters including the sign score. A positive bacterial corneal culture was obtained in 190 (83%) of the 229 enrolled patients. The distribution of the species of bacterial organisms was similar in each treatment group and no significant difference in the percentage of isolates between the groups was observed. Twelve (5.2%) of the treated patients had serious complications (perforation or enucleation). No serious events attributable to therapy occurred during the study and all treatments were safe and well tolerated. CONCLUSION: No difference in healing rate, cure rate, or complications between fortified cephazolin and tobramycin, ofloxacin, or moxifloxacin was seen in this study. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/17822972/Clinical_efficacy_of_moxifloxacin_in_the_treatment_of_bacterial_keratitis:_a_randomized_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(06)01614-9 DB - PRIME DP - Unbound Medicine ER -