Inflammatory response after phacoemulsification treated with 0.5% prednisolone acetate or vehicle.

PURPOSE: To compare the inflammatory response after phacoemulsification and intraocular lens implantation, using postoperative treatment with 0.5% prednisolone acetate eye drops or vehicle. DESIGN: A multi-center randomized double-masked vehicle-controlled, parallel group phase IV study. METHODS: Sixty-two eyes of 62 patients undergoing phacoemulsification were examined at five German university eye hospitals (Mainz, Heidelberg, Bonn, Erlangen, Frankfurt/Main). Patients received either 0.5% prednisolone acetate eye drops (group 1) or vehicle eye drop solution (group 2) four times a day until day 2, then open-label treatment with 0.5% prednisolone acetate eye drops four times a day continued until day 14 for all patients. Postoperative inflammation was evaluated by using laser flare photometry. Secondary efficacy variables included visual acuity, intraocular pressure, corneal edema, bulbar conjunctival hyperemia and ocular discomfort. RESULTS: In group 1, median flare rose from 7.4 photon counts/ms preoperatively to 31.0 photon counts/ms at day 1. In group 2, the flare increased from 8.6 photon counts/ms preoperatively to 30.5 photon counts/ms at day 1. The differences between the groups were not statistically significant. At day 3, flare measures were reduced in group 1 but remained fairly unchanged in group 2 (20.8 photon counts/ms vs 32.6 photon counts/ms), which was statistically significant (p = 0.0055). At day 14, photon counts were comparable in both groups (13.0 photon counts/ms vs 11.4 photon counts/ms), respectively. Both groups were comparable regarding secondary efficacy variables. CONCLUSIONS: 0.5% prednisolone acetate appeared to be significantly more effective as vehicle in controlling intraocular inflammation after phacoemulsification; both groups had a similar safety profile.

Bioavailability of opipramol from a film-coated tablet, a sugar-coated tablet and an aqueous solution in healthy volunteers.

Opipramol (4-[3-(5H-dibenz[b,f]-azepine-5-yl)-propyl]-1-piperazine-ethanol dihydrochloride, CAS 315-72-0) is regarded as an anxiolytic compound with antidepressant properties, and it is one of the most frequently prescribed psychotropic drugs in Germany. In two open, randomized cross-over studies in 20 (study 1) and 18 (study II) healthy volunteers, the relative bioavailability of 50 mg opipramol-2HCl from a sugar-coated tablet was compared with an aqueous solution, and of 100 mg opipramol-2HCl from a newly developed film-coated tablet was compared with the sugar-coated tablet. The concentrations of opipramol were determined in plasma by high-performance liquid chromatography (HPLC) with photometric detection. The mean dose corrected kinetic parameters of opipramol were similar after administration of all formulations. The peak concentrations of opipramol were 13-15 ng ml-1 (study I) and 28 ng ml-1 (study II). They were achieved after 3 h. The area under the plasma concentration-time curve was about 170 ng ml-1 h (study I) and about 320 ng ml-1 h (study II). The terminal plasma half-life was 11 h. Bioequivalence was proven between sugar-coated tablet and aqueous solution, and between film-coated tablet and sugar-coated tablet, respectively. In addition, in study II the plasma concentrations and pharmacokinetic parameters of the metabolites opipramol N-oxide and deshydroxyethyl opipramol were determined.