Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers.
OBJECTIVE
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.


CONCLUSIONS
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.
Shah
Vinit Mahendra
VM
Cornea and Refractive Surgery Services and daggerDepartment of Ocular Microbiology, Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Tandon
Radhika
R
Satpathy
Gita
G
Nayak
Niranjan
N
Chawla
Bhavna
B
Agarwal
Tushar
T
Sharma
Namrata
N
Titiyal
Jeewan S
JS
Vajpayee
Rasik B
RB
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D002437:Cefazolin / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077266:Moxifloxacin; D011446:Prospective Studies; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D014031:Tobramycin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity; D055815:Young Adult
D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D002437:Cefazolin; D000077734:Gatifloxacin; D000077266:Moxifloxacin; D014031:Tobramycin