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Randomized Clinical Study for Comparative Evaluation of Fourth-Generation Fluoroquinolones With the Combination of Fortified Antibiotics in the Treatment of Bacterial Corneal Ulcers

Shah, Vinit Mahendra MD; Tandon, Radhika MD, DipNB, FRCSEd, FRCOphth; Satpathy, Gita MD; Nayak, Niranjan MD, DipNB; Chawla, Bhavna MS; Agarwal, Tushar MD; Sharma, Namrata MD; Titiyal, Jeewan S MD; Vajpayee, Rasik B MS, FRCSEd, FRANZCO

doi: 10.1097/ICO.0b013e3181ca2ba3
Clinical Science

Purpose: Comparative evaluation of efficacy of monotherapy with moxifloxacin (0.5%) or gatifloxacin (0.3%) with combination therapy of cefazolin (5%) and tobramycin (1.3%) in treatment of bacterial corneal ulcers.

Methods: Patients diagnosed with bacterial keratitis (ulcer diameter 2-8 mm) were randomized to 1 of the 3 treatment groups (tobramycin 1.3% and cefazolin 5%, gatifloxacin 0.3%, or moxifloxacin 0.5%). After obtaining corneal scrapings, assigned study medication was instilled hourly for 48 hours and tapered as per clinical response. Healing of ulcer, duration to cure, adverse reactions, antibiogram profile, treatment failures, final visual acuity, and corneal opacity size were evaluated.

Results: A total of 61 patients were enrolled [cefazolin and tobramycin (n = 20), gatifloxacin (n = 21), and moxifloxacin (n = 20)]. Overall, 57 patients (93%) healed on treatment. On comparison of the mean time taken to heal, no statistically significant difference was found among all the 3 treatment groups (P = 0.98). Positive bacterial culture was obtained in only 38 patients (62%). There was no significant difference in the bacterial isolates in each treatment group. There were 4 (7%) treatment failures (perforation or nonhealing ulcer): 1 (5%) each in moxifloxacin and gatifloxacin group and 2 (10%) in fortified antibiotics group. All regimens were well tolerated.

Conclusion: The study failed to find a difference in the efficacy of monotherapy with fourth-generation fluoroquinolones in the treatment of bacterial corneal ulcers of 2-8 mm size when compared with combination therapy of fortified antibiotics.

From the *Cornea and Refractive Surgery Services and †Department of Ocular Microbiology, Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India; and ‡Cornea and Cataract Surgery Services, Centre for Eye Research Australia, University of Melbourne, Melbourne, Victoria, Australia.

Received for publication February 14, 2009; revision received September 24, 2009; accepted November 2, 2009.

The research was not sponsored by any organization. There is no financial relationship with any organization.

The authors have full control of all primary data, and they agree to allow Cornea to review their data upon request.

Reprints: Radhika Tandon, R.P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi 110029, India (e-mail:

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