Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis
| Autor: | Kirk Bateman, Timothy L. Comstock, Eric M. White, Jonathan I Macy |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Intraocular pressure Visual acuity Adolescent Loteprednol etabonate Anti-Inflammatory Agents Keratoconjunctivitis Visual Acuity Dexamethasone law.invention Randomized controlled trial law Anti-Allergic Agents Tobramycin Medicine Humans Ocular inflammation Intraocular Pressure Aged Aged 80 and over Blepharitis business.industry Loteprednol Etabonate General Medicine Middle Aged Anti-Bacterial Agents Androstadienes Drug Combinations Treatment Outcome Loteprednol Anesthesia Female medicine.symptom business medicine.drug |
| Zdroj: | Current medical research and opinion. 24(1) |
| ISSN: | 1473-4877 |
| Popis: | This study compared the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; Tobradex) in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis.This was a multicenter, randomized, investigator-masked, parallel-group study. Subjects with clinically diagnosed blepharokeratocon-junctivitis in at least one eye were randomized to LE/T (n = 138) or DM/T (n = 138) administered four times per day, for 14 days. The primary efficacy endpoint was the change from baseline to Day 15 (+/- 1 day) in the signs and symptoms composite score using a non-inferiority metric to compare LE/T to DM/T. Safety endpoints included visual acuity (VA), biomicroscopy, intraocular pressure (IOP) assessments, and adverse events.At Day 15, the mean (SD) change from baseline in the signs and symptoms composite score was -15.2 (7.3) for LE/T-treated subjects and -15.6 (7.7) for DM/T-treated subjects. The upper bound of the 90% confidence interval for the difference in change from baseline was less than the non-inferiority margin not only at Day 15 but also at Day 7 and Day 3 for both the intent-to-treat and per protocol populations. Subjects treated with DM/T experienced a significant increase in IOP versus those treated with LE/T at Day 7, Day 15, and overall (mean [SD] of 0.6 [2.3] vs, -0.1 [2.2], p = 0.03, 1.0 [3.0] vs. -0.1 [2.4], p = 0.01, and 2.3 [2.3] vs. 1.6 [1.7], p = 0.02, respectively).LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP.Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked. |
| Databáze: | OpenAIRE |
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