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J.D. Bartlett, E. Holland, M. Pribadi–Behm, D. Usner, M. Paterno; Ocular Tolerance and IOP Effects of Zylet® Compared to TobraDex® Administered Four Times Daily for Four Weeks in Healthy Volunteers . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5559.
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To compare the ocular tolerability and steroid–induced intraocular pressure (IOP) effects of Zylet (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) with those of TobraDex.
Three hundred–six subjects (Zylet, 156 subjects; TobraDex, 150 subjects) were randomized into this double–masked, multi–center, parallel–group clinical trial. Subjects received either Zylet or TobraDex QID in both eyes for 28 days. Ocular comfort/tolerability (i.e., pain, stinging/burning, irritation, itchiness, foreign–body sensation, dryness, and light sensitivity) and IOP were obtained at each of 6 study visits. Comfort/tolerability was rated from 0 (extremely uncomfortable) to 100 (extremely comfortable) and was obtained at study visits as well as by daily diary entries.
For the Zylet group, a statistically significant improvement in pain was noted in the mean change from Baseline to the final week of diary assessments (p= 0.0071), whereas for TobraDex, a significant deterioration in light sensitivity occurred (p= 0.0076). Overall, Zylet was shown to be non–inferior to TobraDex for all comfort/tolerability parameters evaluated in this regard. Changes in comfort/tolerability from Baseline to each subsequent study visit revealed a statistically significant difference between the treatment groups for all comfort/tolerability parameters (p≤ 0.0488). All of these changes favored Zylet in terms of better comfort/tolerability. Increases from baseline IOP that were ≥ 10 mmHg were seen in both treatment groups (Zylet, 1.95% of subjects; TobraDex, 7.48% of subjects). The difference in the rate of IOP increases was statistically significant (p= 0.0280).
Zylet was non–inferior to TobraDex for all of the comfort/tolerability parameters evaluated in this study and produced statistically significant improvements in pain scores, while TobraDex produced statistically significant deterioration in light sensitivity scores. Increases in IOP of ≥ 10 mmHg were seen in both treatment groups, but nearly 4 times as many subjects in the TobraDex group experienced this degree of IOP elevation. These results suggest that the use of Zylet for the treatment of ocular inflammation associated with the need for combination therapy may result in fewer instances of increased IOP and a similar, or perhaps better, ocular comfort/tolerability profile when compared to TobraDex.
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