Loteprednol Etabonate 0.5%/Tobramycin 0.3% Compared with Dexamethasone 0.1%/Tobramycin 0.3% for the Treatment of Blepharitis

Ocul Immunol Inflamm. 2017 Apr;25(2):267-274. doi: 10.3109/09273948.2015.1115879. Epub 2016 Jan 20.

Abstract

Purpose: To compare the efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in reducing select signs of blepharitis.

Methods: Data were pooled from two studies (one from the USA; one from China) of adults (n = 627) with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks (safety population). Efficacy analyses included 495 eyes (247 LE/T, 248 DM/T) with any baseline sign of blepharitis.

Results: At Day 15, the least squares mean change from baseline in composite blepharitis severity was similar between LE/T (-2.86) and DM/T (-2.99) (90% CI for mean treatment difference: -0.35, 0.11). Intraocular pressure (IOP) increases ≥10 mmHg over baseline were reported for 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).

Conclusions: LE/T was similarly effective in reducing the signs of blepharitis compared with DM/T, but demonstrated a better safety profile with respect to changes in IOP.

Keywords: Blepharitis; dexamethasone; loteprednol etabonate; tobramycin.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Allergic Agents / therapeutic use*
  • Anti-Bacterial Agents / therapeutic use*
  • Asian People
  • Blepharitis / diagnosis
  • Blepharitis / drug therapy*
  • Blepharitis / physiopathology
  • Dexamethasone / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / therapeutic use*
  • Humans
  • Loteprednol Etabonate / therapeutic use*
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Tobramycin / therapeutic use*
  • Treatment Outcome
  • Visual Acuity / physiology
  • Young Adult

Substances

  • Anti-Allergic Agents
  • Anti-Bacterial Agents
  • Glucocorticoids
  • Ophthalmic Solutions
  • Dexamethasone
  • Tobramycin
  • Loteprednol Etabonate