• Minjie Chen, Lan Gong, Xinghuai Sun, Yangshun Gu, Xiangge He, Jia Qu, Lili Wang, Mingzhi Zhang, and Xingwu Zhong.
• Eye and ENT Hospital of Fudan University , Shanghai , China.
• Curr Med Res Opin. 2012 Mar 1; 28 (3): 385394385-94.

ObjectiveTo compare the efficacy and safety of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in a Chinese population with ocular inflammation associated with blepharokeratoconjunctivitis (BKC).Research Design And MethodsThis study was a multicenter, randomized, investigator-masked, parallel-group clinical trial. Patients aged ≥18 years with a clinical diagnosis of BKC in at least one eye received LE/T or DM/T administered 4 times daily for 2 weeks. At baseline and on days 3, 8, and 15 (visits 2, 3, and 4), clinical assessments of ocular signs and symptoms, visual acuity (VA), biomicroscopy, and intraocular pressure (IOP) were performed in both eyes.Main Outcome MeasuresThe primary efficacy endpoint was the change from baseline (CFB) to visit 4 in the signs and symptoms composite score in designated study eyes using a non-inferiority metric to compare LE/T to DM/T. Safety evaluation included adverse events, biomicroscopy findings, and changes in VA and IOP.Clinical Trial RegistrationNCT number, NCT01028027.ResultsA total of 308 patients were included in the per protocol population (n = 156 LE/T, n = 152 DM/T). A significant CFB in composite signs and symptoms was seen with both treatments at each follow-up visit (p < 0.0001). The mean (SD) CFB at visit 4 was -11.63 (4.56) and -12.41 (4.71) in the LE/T and DM/T groups, respectively, and the upper bound of the 90% confidence interval for the difference was less than the prespecified non-inferiority margin. Comparable results were found for secondary efficacy outcomes. Patients treated with DM/T experienced a significantly greater increase in mean CFB in IOP compared to those treated with LE/T at all follow-up visits (p ≤ 0.0186) and nearly twice as many IOP elevations ≥5 mmHg (p = 0.0020).ConclusionTreatment with LE/T was at least as effective as DM/T in Chinese patients with BKC and had a better safety profile with respect to change in IOP.

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