Evaluation of Moxifloxacin 0.5 % in Treatment of Nonperforated Bacterial Corneal Ulcers: A Randomized Controlled Trial

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• 作者：Namrata Sharma ; MD<sup>1sup><sup> ; sup><sup>namrata.sharma@gmail.comsup> ; Manik Goel ; MD<sup>1sup> ; Shubha Bansal ; DNB<sup>1sup> ; Prakashchand Agarwal ; MD<sup>1sup> ; Jeewan S. Titiyal ; MD<sup>1sup> ; Ashish D. Upadhyaya ; MSc<sup>2sup> ; Rasik B. Vajpayee ; FRCSEd ; FRANZCO<sup>1sup><sup> ; sup><sup>3sup>
• 刊名：Ophthalmology
• 出版年：2013
• 出版时间：June, 2013
• 年：2013
• 卷：120
• 期：6
• 页码：1173-1178
• 全文大小：288 K

文摘

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ss=""h4"">Purpose

To compare the equivalence of moxifloxacin 0.5 % with a combination of fortified cefazolin sodium 5 % and tobramycin sulfate 1.3 % eye drops in the treatment of moderate bacterial corneal ulcers.

ss=""h4"">Design

Randomized, controlled, equivalence clinical trial.

ss=""h4"">Participants and Controls

Microbiologically proven cases of bacterial corneal ulcers were enrolled in the study and were allocated randomly to 1 of the 2 treatment groups.

ss=""h4"">Intervention

Group A was given combination therapy (fortified cefazolin sodium 5 % and tobramycin sulfate) and group B was given monotherapy (moxifloxacin 0.5 % ).

ss=""h4"">Main Outcome Measures

The primary outcome variable for the study was percentage of the ulcers healed at 3 months. The secondary outcome variables were best-corrected visual acuity and resolution of infiltrates.

ss=""h4"">Results

Of a total of 224 patients with bacterial keratitis, 114 patients were randomized to group A, whereas 110 patients were randomized to group B. The mean ¡À standard deviation ulcer size in groups A and B were 4.2¡À2 and 4.41¡À1.5 mm, respectively. The prevalence of coagulase-negative Staphylococcus (40.9 % in group A and 48.2 % in group B) was similar in both the study groups. A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8 % ) in group A and 88 patients (81.4 % ) in group B at 3 months. The observed percentage of healing at 3 months was less than the equivalence margin of 20 % . Worsening of ulcer was seen in 18.2 % cases in group A and in 18.5 % cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P = 0.065). No serious events attributable to therapy were reported.

ss=""h4"">Conclusions

Corneal healing using 0.5 % moxifloxacin monotherapy is equivalent to that of combination therapy using fortified cefazolin and tobramycin in the treatment of moderate bacterial corneal ulcers.

ss=""h4"">Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.