Current medical research and opinion · 2005
A clinical comparison of two different prednisolone acetate formulations in patients undergoing cataract surgery.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Gayton Johnny L
Аннотация
PURPOSE: This study was conducted to evaluate the efficacy of two topical steroid prednisolone preparations (Econopred Plus 1%, prednisolone acetate 1%: EPP; Pred Fortedagger 1%, prednisolone acetate 1%: PF) in reducing postoperative inflammation in cataract patients.
METHODS: This was a 4 week, randomized, parallel-group, single-center, active-controlled study. One group of patients received postoperative topical EPP while the other group received postoperative topical PF. Both medications were dosed 4 times per day for 14 days and then BID until the container was empty. Both groups of patients received diclofenac sodium QID for 14 days and hydroxypropyl guar (HP-Guar, Systane) QID for 7 days then PRN (or as directed). The presence of corneal surface keratitis, anterior chamber cells and flare (scales 0-3 for keratitis, 0-5 for cells and 0-4 for flare; 0 = none) was evaluated by slit lamp biomicroscopy.
RESULTS: EPP produced significantly lower (P < 0.05) anterior chamber flare scores 14 days following surgery (mean +/- SD: 0.86 +/- 0.53) than PF (1.08 +/- 0.40). Otherwise, there were no differences observed between the 2 treatments with respect to keratitis, anterior chamber flare or cells at postop days 1, 7, or 28.
CONCLUSIONS: This comparative trial demonstrated that both formulations of prednisolone acetate 1% have similar efficacy in the treatment of postoperative ophthalmologic inflammation.
METHODS: This was a 4 week, randomized, parallel-group, single-center, active-controlled study. One group of patients received postoperative topical EPP while the other group received postoperative topical PF. Both medications were dosed 4 times per day for 14 days and then BID until the container was empty. Both groups of patients received diclofenac sodium QID for 14 days and hydroxypropyl guar (HP-Guar, Systane) QID for 7 days then PRN (or as directed). The presence of corneal surface keratitis, anterior chamber cells and flare (scales 0-3 for keratitis, 0-5 for cells and 0-4 for flare; 0 = none) was evaluated by slit lamp biomicroscopy.
RESULTS: EPP produced significantly lower (P < 0.05) anterior chamber flare scores 14 days following surgery (mean +/- SD: 0.86 +/- 0.53) than PF (1.08 +/- 0.40). Otherwise, there were no differences observed between the 2 treatments with respect to keratitis, anterior chamber flare or cells at postop days 1, 7, or 28.
CONCLUSIONS: This comparative trial demonstrated that both formulations of prednisolone acetate 1% have similar efficacy in the treatment of postoperative ophthalmologic inflammation.