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S.S. Rhee, F.S. Mah; Comparison of Tobradex (Tobramycin/Dexamethasone) and Zylet (Tobramycin/Loteprednol) in the Management of Blepharo–Keratoconjunctivitis . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4965.
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Previously, we reported on a comparison of two regimens (tobramycin/dexamethasone, Tobradex® Suspension [Alcon Laboratories, Ft. Worth, TX] and tobramycin/loteprednol, extemporaneously formulated) on the ability to rapidly control external ocular inflammation. In this clinical trial, we compared the ability of two commercially formulated antibiotic–steroid combinations, Tobradex® Suspension and ZyletTM (Bausch & Lomb Inc., Rochester, NY) to rapidly control the inflammation in blepharo–keratoconjunctivitis.
This was a randomized, parallel–group, double masked study in forty eyes of forty patients with blepharo–keratoconjunctivitis. Patients received either tobramycin/loteprednol 0.5%, ZyletTM (ZYL) or tobramycin/dexamethasone 0.1%, Tobradex® (TBD) twice daily in the test eye according to the randomization schedule. At baseline, the ocular surface was graded on a scale of 3 (extensive) to 0 (minimum) for 4 components: blepharitis, ocular discharge, conjunctivitis, and corneal punctate epithelial keratopathy (PEK). Only those patients with at least moderate inflammation (cumulative score greater than 6) were included in the study. At follow–up 3–5 days later, the ocular surface was re–graded to evaluate treatment response. The individual and total scores were then compared between the two treatment groups using the Student’s t–test.
There was no statistical difference in pre–treatment scores for the 4 components [blepharitis (p=0.31), discharge (p=0.62), conjunctivitis (p=1.0), and PEK (p=0.57)] or total ocular inflammation score between the two groups (p=0.87). Mean post–treatment scores are reported: post–ZYL and post–TBD, with p values. Total ocular surface scores (sum of 4 components) 3.4 and 1.8 (p=0.002). Blepharitis scores 1.35 and 0.9 (p=0.017). Discharge scores 0.6 and 0.2 (p=0.024). Conjunctivitis scores 0.6 and 0.15 (p=0.013). Corneal PEK scores 0.85 and 0.55 (p=0.065). The mean time to follow up was 3.65 and 3.5 days (p=0.576). There was no change in intraocular pressure (p=0.88) or visual acuity (p=0.782) between the two groups. There were no adverse events.
In this study of blepharo–keratoconjunctivitis, the two regimens provided a comparable rapid decrease in corneal PEK. However, Tobradex® Suspension significantly decreased clinical signs of ocular inflammation (i.e., blepharitis, discharge, conjunctivitis) and total ocular inflammation scores when compared with ZyletTM.
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