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Timothy Comstock, Heleen H DeCory; Zylet (loteprednol etabonate 0.5%/tobramycin 0.3%) Compared with Tobradex (dexamethasone 0.1%/tobramycin 0.3%) for the treatment of blepharitis in a large international population. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4867.
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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 signs of blepharitis.
Data were pooled from two multicenter, randomized, investigator-masked, parallel-group clinical trials with similar designs (one US; one China) in adult patients with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks. We evaluated the change from baseline to Day 15 in individual blepharitis signs (lid hyperemia, lid scaling/crusting, and lid margin hypertrophy; each graded on a 5-point scale from 0 [none] to 4 [severe]), and composite (combined) blepharitis signs. The study eye was the eye with the greatest severity at baseline or the right eye if severity was equal. Outcomes were evaluated for the entire pooled study population and for the quartile of patients having the most severe signs at baseline (composite severity ≥6). Changes in intraocular pressure (IOP) were analyzed separately for the US and Chinese populations.
The pooled ITT population included 495 patients/eyes (247 LE/T, 248 DM/T). There was no difference between treatments in the proportion of eyes with a ≥1-grade reduction (improvement) from baseline in individual or composite blepharitis signs (Table 1). For patients in the highest severity quartile at baseline and evaluated on Day 15 (n=120), blepharitis signs were fully resolved in 23.7% (14/59) of eyes treated with LE/T and 21.3% (13/61) of the eyes treated with DM/T (P=0. 8284). Mean IOP increased significantly with DM/T compared with LE/T beginning at Day 7 (US study) or Day 3 (China study) (P≤0.0339). IOP increases of ≥10 mm Hg over baseline were noted in 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).
In this pooled analysis, LE/T was effective in reducing the signs of blepharitis with similar results compared to DM/T. 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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