Gatifloxacin 0.3% Versus Fortified Tobramycin-Cefazolin in Treating Nonperforated Bacterial Corneal Ulcers: Randomized, Controlled Trial.
OBJECTIVE
To compare the equivalence of gatifloxacin 0.3% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of nonperforated bacterial corneal ulcers.


METHODS
In randomized, controlled, equivalence clinical trials, microbiologically proven cases of nonperforated bacterial corneal ulcers were enrolled and were allocated randomly to one of the 2 treatment groups. Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate 1.3%) and group B was given monotherapy (gatifloxacin 0.3%). The primary outcome measure was the percentage of corneal ulcers that healed at 3 months of follow-up.


RESULTS
Out of 204 patients enrolled, 103 patients were randomized to group A, whereas 101 patients were randomized to group B. The mean ± SD of ulcer size in groups A and B were 4.35 ± 1.36 and 4.18 ± 1.31 mm, respectively (P = 0.376). The most common bacterial isolate was coagulase-negative Staphylococcus (51.5% in group A and 45.5% in group B). Worsening of the ulcer was seen in 27.2% (28/103) of the cases in group A and in 21.8% (22/101) of the cases in group B. The percentage healing difference was calculated to be 5.4% (90% confidence interval, -4.5 to 15.3). No serious events attributable to therapy were reported in any group.


CONCLUSIONS
Using the prespecified definition of equivalence of ±20%, this trial found evidence that gatifloxacin monotherapy was equivalent to combination therapy with cefazolin and tobramycin for the treatment of nonperforated bacterial corneal ulcers.
*Department of Ophthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India; †Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India; and ‡Department of Ocular Microbiology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Namrata
N
Sharma
Tarun
T
Arora
Vikas
V
Jain
Tushar
T
Agarwal
Rajat
R
Jain
Vaibhav
V
Jain
Chander Prakash
CP
Yadav
Jeewan
J
Titiyal
Gita
G
Satpathy
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D002437:Cefazolin / Q000008:administration & dosage*; D003315:Cornea / Q000382:microbiology / Q000473:pathology; D003320:Corneal Ulcer / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome; D014792:Visual Acuity
D000900:Anti-Bacterial Agents; D002437:Cefazolin; D014031:Tobramycin