PURPOSE: To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension. METHODS:Three hundred six healthy volunteers received either loteprednol etabonate/tobramycin (n = 156) ordexamethasone/tobramycin (n = 150) at 4-hour intervals 4 times a day in both eyes for 28 days in this randomized, double-masked, multicenter, parallel-group trial. IOP, visual acuity (VA), and ocular health were assessed at all study visits (days 1, 3, 8, 15, 22, and 29), whereas undilated direct ophthalmoscopy was completed at the baseline and final visits. Adverse events (AEs) were assessed at all follow-up visits. RESULTS: The number of subjects experiencing IOP increases of >or=10 mm Hg from baseline at any study visit for the loteprednol etabonate/tobramycin group (3 subjects, 1.95%) was significantly lower than that for the dexamethasone/tobramycin group (11 subjects, 7.48%; P = 0.0280), as were mean changes from baseline IOP (P < 0.05 at all visits). The lowest VA recorded for any subject at any visit was 20/40 and reductions of >or=2 lines at any visit were observed in 14 (4.55%) eyes for loteprednol etabonate/tobramycin and in 23 (7.82%) eyes for dexamethasone/tobramycin (P = 0.1257). Both treatments were well tolerated. CONCLUSIONS:Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.
RCT Entities:
PURPOSE: To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension. METHODS: Three hundred six healthy volunteers received either loteprednol etabonate/tobramycin (n = 156) or dexamethasone/tobramycin (n = 150) at 4-hour intervals 4 times a day in both eyes for 28 days in this randomized, double-masked, multicenter, parallel-group trial. IOP, visual acuity (VA), and ocular health were assessed at all study visits (days 1, 3, 8, 15, 22, and 29), whereas undilated direct ophthalmoscopy was completed at the baseline and final visits. Adverse events (AEs) were assessed at all follow-up visits. RESULTS: The number of subjects experiencing IOP increases of >or=10 mm Hg from baseline at any study visit for the loteprednol etabonate/tobramycin group (3 subjects, 1.95%) was significantly lower than that for the dexamethasone/tobramycin group (11 subjects, 7.48%; P = 0.0280), as were mean changes from baseline IOP (P < 0.05 at all visits). The lowest VA recorded for any subject at any visit was 20/40 and reductions of >or=2 lines at any visit were observed in 14 (4.55%) eyes for loteprednol etabonate/tobramycin and in 23 (7.82%) eyes for dexamethasone/tobramycin (P = 0.1257). Both treatments were well tolerated. CONCLUSIONS:Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.
Authors: Timothy L Comstock; Michael R Paterno; Kirk M Bateman; Heleen H Decory; Matthew Gearinger Journal: Paediatr Drugs Date: 2012-04-01 Impact factor: 3.022
Authors: Christian Clement; Joseph A Capriotti; Manish Kumar; Jeffery A Hobden; Timothy P Foster; Partha S Bhattacharjee; Hilary W Thompson; Rashed Mahmud; Bo Liang; James M Hill Journal: Invest Ophthalmol Vis Sci Date: 2011-01-21 Impact factor: 4.799