Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% withdexamethasone 0.1%/tobramycin0.3% in the treatment of blepharokeratoconjunctivitis

Abstract

Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.

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

“…Data were pooled from two multicenter, randomized, investigator-masked, parallel-group clinical trials with similar designs, one conducted at 17 sites in the USA 10 and the other at seven sites in China. 11 Patients were enrolled from January 2007 through June 2007 for the US study (NCT00447577) and from October 2009 through February 2010 for the China study (NCT01028027).…”

“…Full inclusion and exclusion criteria have been previously described. 10,11 Investigators determined the baseline severity of ocular signs of all three disease components: blepharitis (lid hyperemia, lid scaling or crusting, lid margin hypertrophy); conjunctivitis (conjunctival hyperemia, conjunctival discharge, conjunctival chemosis); and keratitis (corneal punctate epithelial keratopathy), using a 5-point rating scale of 0 (none); 1 (minimal/trace); 2 (mild); 3 (moderate); or 4 (severe). In order to be eligible for the current efficacy analysis, patients were required to have a baseline blepharitis composite severity ≥1 in at least one eye (maximum possible composite severity = 12).…”

“…Demographic characteristics of the safety populations (313 LE/T; 314 DM/T), comprised of all patients in the pooled study population who received at least one dose of study medication, were also similar at baseline as reported for the source studies (data not shown). 10,11 Of the patients in the ITT efficacy population, 124 patients (59 LE/T; 65 DM/T) had a baseline severity ≥6 for composite blepharitis.…”

“…9 In two multicenter, randomized, investigatormasked, parallel-group studies, one in a US population, the other in a Chinese population, LE/T was demonstrated to be non-inferior to dexamethasone 0.1%/tobramycin 0.3% (DM/T) in decreasing the composite signs and symptoms of ocular inflammation in patients with blepharokeratoconjunctivitis (BKC) and was associated with less IOP elevation compared with DM/T. 10,11 In the current study, data from these two similar studies were pooled, providing a large, international study population. Given that blepharitis can present as a sole diagnosis, this analysis was designed to specifically analyze the blepharitis outcomes in the pooled dataset and evaluate the comparative efficacy of LE/T and DM/T ophthalmic suspensions for this indication.…”

Comparison of the Safety and Efficacy of Loteprednol Etabonate 0.5%/Tobramycin 0.3% with Dexamethasone 0.1%/Tobramycin 0.3% Following Strabismus Surgery

“…Loteprednol etabonate (LE), a new-generation corticosteroid, has been shown to be an effective anti-inflammatory agent with lesser side effects in anterior segment inflammatory conditions [4][5][6]. Recently, topical combination products of 0.5% LE/0.3% tobramycin (LE/T) or 0.1% DM/0.3% tobramycin (DM/T) are commonly used in the treatment of steroid-responsive ocular inflammation, and a risk of bacterial ocular infection exists [7][8][9][10][11][12][13]. LE/T has been found to be similar to DM/T in its antiinflammatory effects for cataract surgery [8,14].…”