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D. J. Lutz, L. B. Cantor, D. WuDunn, Y. P. Catoira; A Comparison of Three Formulations of Topical Prednisolone Acetate 1% for Control of Post-Glaucoma or Post-Cataract Surgery Inflammation. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4168.
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: To quantitatively asses the therapeutic equivalence of three formulations of prednisolone acetate 1% suspension in the control of post-operative inflammation in eyes which had undergone primary trabeculectomy or cataract extraction after trabeculectomy
51 patients who had either visually significant cataract after glaucoma filtering surgery and elected to undergo cataract surgery or who had medically uncontrolled glaucoma and elected to undergo primary trabeculectomy were selected. This represents approximately 50% of the planned enrollment in this on-going study. Each eye was randomized to receive one of three commercially available formulations of prednisolone acetate 1% suspension (Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon)) administered on a standard post-operative schedule. Objective measurements of intraocular inflammation were obtained with a non-invasive laser flare meter (Kowa Optimed) on post-operative days 1, 7, 14, 30 and 60.
In comparing flare readings for post-operative days 1, 14, 30, and 60, there was no statistically significant difference among the three treatment arms (P values ranging from 0.11 to 0.93 by ANOVA and Kruskal-Wallis). The possible exception is at post-operative day 7, for which Drop A may demonstrate statistically significant less flare than Drop C (P < 0.05 by Kruskal-Wallis, P = 0.09 by ANOVA). Because there was no definitive difference among the three treatment arms in this interim analysis, all patients have remained masked until the completion of this study.
Preliminary data indicates no statistical difference among Pred Forte 1%, Econopred Plus 1% and generic prednisolone acetate 1% in the ability to control post-operative inflammation, with the possible exception at post-operative day 7.
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