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Timothy Comstock, Heleen DeCory, Kirk Bateman; Zylet (loteprednol etabonate 0.5%/tobramycin 0.3%) Compared with Tobradex (dexamethasone 0.1%/tobramycin 0.3%) for the Treatment of Lid Inflammation in Two Populations. Invest. Ophthalmol. Vis. Sci. 2013;54(15):99.
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To compare loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions for the treatment of lid inflammation across two patient populations.
Two multicenter, randomized, investigator-masked, parallel-group clinical trials with similar designs were conducted. In both studies patients aged ≥18 years with blepharokeratoconjunctivitis in at least one eye received LE/T or DM/T administered QID for 2 weeks. The first study was conducted at clinical centers in the US; the second study at clinical centers in China. Signs and symptoms were assessed at baseline and on days 3, 8, and 15. The primary endpoint in this analysis was the change from baseline (CFB) to day 15 in composite blepharitis severity (lid hyperemia, lid scaling or crusting, and lid margin hypertrophy, each measured on a 5-pt scale). Safety outcomes included an assessment of AEs, and changes in visual acuity (VA), biomicroscopy, and intraocular pressure (IOP).
A total of 273 patients (136 LE/T, 137 DM/T) and 354 patients (178 LE/T, 176 DM/T) were included in the ITT population in the US and China studies, respectively. Patients in the US study were primarily White (>80%); all patients in the China study were Chinese. A significant CFB in blepharitis severity was seen in both populations with both treatments at each follow-up visit. At day 15, the reduction in composite blepharitis severity was 68.8% for LE/T vs. 66.7% for DM/T in the US study and 75.0% for LE/T vs. 77.4% for DM/T in the China study. Patients treated with DM/T experienced a significant increase in IOP compared to those patients treated with LE/T beginning at day 8 (US study) or Day 3 (China study) (P≥0.0339). In both studies twice as many patients in the DM/T group experienced IOP increases of ≥ 5 mm Hg over baseline compared to the LE/T group. In the US study, one patient (DM/T group), while in the China study, 19 patients (6 LE/T; 13 DM/T) experienced an IOP increase of ≥10 mm Hg over baseline.
LE/T was effective in the treatment of lid inflammation with similar results compared to DM/T in both a primarily White population and a Chinese population. LE/T had a better safety profile with respect to change in IOP especially in Chinese patients considered at higher risk for steroid-induced IOP.
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