Comparison of tobramycin 0.3%/dexamethasone 0.1% and tobramycin 0.3%/loteprednol 0.5% in the management of blepharo-keratoconjunctivitis.

In this clinical trial, investigators compared the effectiveness of 2 commercially formulated antibiotic/steroid combinations - tobramycin 0.3%/dexamethasone 0.1% (Tobradex; Alcon, Fort Worth, Tex) and tobramycin 0.3%/loteprednol 0.5% (Zylet; Bausch &; Lomb Inc., Rochester, NY) - for rapidly controlling inflammation in patients with blepharo-keratoconjunctivitis. Investigators in this randomized, parallel-group, double-masked study examined 40 eyes of 40 patients with blepharo-keratoconjunctivitis. Patients received tobramycin 0.3%/dexamethasone 0.1% or tobramycin 0.3%/loteprednol 0.5% twice daily in the test eye, according to the randomization schedule. At baseline, the ocular surface was graded on a scale of 3 (extensive) to 0 (minimum) for 4 components: blepharitis, conjunctivitis, ocular discharge, and corneal punctate epithelial keratopathy (PEK). Only those patients with moderate to extensive inflammation (cumulative score >6) were included in the study. At follow-up 3 to 5 d later, the ocular surface was regraded so that treatment response could be evaluated. No statistically significant difference was noted between groups in pretreatment scores for blepharitis (P=.31), discharge (P=.62), conjunctivitis (P=1.0), and PEK (P=.57), or for total ocular inflammation (P=.87). Mean posttreatment scores were as follows: total ocular surface scores, 1.8 and 3.4 (P=.002); blepharitis scores, 0.9 and 1.35 (P=.017); discharge scores, 0.2 and 0.6 (P=.025); and conjunctivitis scores, 0.15 and 0.6 (P=.013) for tobramycin/dexamethasone and tobramycin/loteprednol, respectively. Corneal PEK scores were not significantly different between treatments. Tobramycin 0.3%/dexamethasone 0.1% significantly decreased clinical signs of ocular inflammation (ie, blepharitis, discharge, conjunctivitis) and total ocular inflammation scores when compared with tobramycin 0.3%/loteprednol 0.5% in patients with moderate to severe blepharo-keratoconjunctivitis. The 2 regimens also provided comparably rapid decreases in corneal PEK.

RCT Entities:   Population Interventions Outcomes