title: Comparison of tobramycin 0.3%/dexamethasone 0.1% and tobramycin 0.3%/loteprednol 0.5% in the management of blepharo-keratoconjunctivitis.
abstract: 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.
authors.affiliation: University of Pittsburgh School of Medicine, Department of Ophthalmology, UPMC Eye Center, Pittsburgh, PA 15213-2588, USA.
authors.forename: Steven S
authors.initials: SS
authors.lastname: Rhee
authors.forename: Francis S
authors.initials: FS
authors.lastname: Mah
mesh_terms: D000730:Androstadienes / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D001762:Blepharitis / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004355:Drug Stability; D005938:Glucocorticoids / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D007637:Keratoconjunctivitis / Q000188:drug therapy*; D000069559:Loteprednol Etabonate; D008853:Microscopy; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions; D014031:Tobramycin / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D000730:Androstadienes; D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D013535:Suspensions; D003907:Dexamethasone; D014031:Tobramycin; D000069559:Loteprednol Etabonate