The most pronounced differences between the

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The statistical evaluation was performed using SAS software package (version 6; SAS Institute Inc., Cary, NC, USA). All data were listed and trial summary tables were provided. Exploratory statistical tests were performed to compare the visual function tests following BAY 38–9456 and placebo, respectively. Quantitative target variables were subjected to an analysis of covariance (ANCOVA) with the factors: treatment, period, subject, sequence, time, and the interactions period*time, treatment*time and the baseline value as a covariate. BAY 38–9456 40 mg (vardenafil hydrochloride) was generally well tolerated. two treatment groups were observed for

total error score 1 and 6

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To determine ocular side effects of vardenafil with special regard to color vision and retinal function. This was a single center, randomized, double-blind, placebo-controlled, twofold crossover study with an administration of a single oral dose of two 20 mg tablets of BAY 38–9456 (vardenafil hydrochloride) or corresponding placebo in 24 healthy male subjects. Ocular investigations included Farnsworth–Munsell D100 color vision test, electroretinogram, and basic ophthalmological examinations like visual acuity, visual field, and slit-lamp of anterior segment and fundus. Compared to placebo, administration of vardenafil hydrochloride lead to a temporary significant increase of Farnsworth–Munsell D100 total error score after 1 and 6 hours as well as in error lines 3 and 4 after 1 hour. Twenty-four hours after administration there was no significant alteration of total error score or of any error line.

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While latency of electroretinogram b-wave remained unaffected, amplitudes showed a significant decrease compared to placebo 1 hour following administration. While other ocular examinations did not reveal any differences in general some mild to moderate but no serious adverse events have been reported. Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects. Vardenafil (Levitra®; Bayer AG, Leverkusen, Germany) has been developed as an inhibitor of phosphodiesterase 5 (PDE-5) for the treatment of erectile dysfunction. PDE-5 inhibitors like vardenafil or sildenafil (Viagra®) do not have a direct relaxant effect on the corpus cavernosum; however, they enhance the effect of nitric oxide (NO) by inhibiting PDE-5, which is responsible for degradation of cyclic guanosine monophosphate in the corpus cavernosum.Citation1 When sexual stimulation causes local release of NO, inhibition of PDE-5 by vardenafil causes smooth muscle relaxation and inflow of blood to the corpus cavernosum.Citation2,Citation3 Vardenafil has been shown to be effective and safe when administered to patients with erectile dysfunction in placebo-controlled studies over a dose range of 5–20 mg once daily and up to 40 mg twice daily in multiple-dose Phase I and II studies.Citation4–Citation6 The most frequent adverse events (AEs) were headache, flush, rhinitis, and dyspepsia.Citation7,Citation8 Typical ocular side effects seen under treatment with PDE-5 inhibitors are disturbed color vision and temporary effects on the electroretinogram (ERG), which may be due to the fact that PDE-6, typically located in the eye, is also inhibited to a certain degree by PDE-5 inhibitors;Citation9–Citation14 this may depend on the selectivity of PDE-5 inhibition.Citation15 However, these side effects have been exclusively investigated for sildenafil. hours after drug administration, and for error

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score lines 3, and 4 one

hour after drug administration, indicating an

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impairment of color discrimination particularly in

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representing color vision of blue/green and purple.

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Therefore, this study was designed to especially investigate the possible influence of vardenafil-induced PDE-5 inhibition on ocular side effects and the function of the retina. The primary objective of the study was to investigate the possible influence of a single oral dose of 40 mg of vardenafil on color vision in normal-eyed male subjects measured by performing Farnsworth–Munsell 100 test at 1, 6 and 24 hours after drug administration. Secondary objectives of the study were further investigations of the eye including effects on retinal function as well as the safety and overall tolerability of vardenafil. To our knowledge this is the first investigation on retinal function following vardenafil administration and the first placebo-controlled study on ocular side effects for the use of vardenafil at all. This was a single-center, randomized, double-blind, placebo-controlled, twofold crossover study with an administration of a single oral dose of a 40 mg BAY 38–9456 (vardenafil hydrochloride) given as 2 tablets of 20 mg in 24 healthy male subjects.

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The trial was registered at the District Council Cologne, Germany under the registration number BAY 38-9456 / 10197. In detail, demographic features of all subjects are listed in . Starting from the time of administration, subsequent investigations of the eye were performed according to the study flowchart (). Blood drawings were taken for the determination of the plasma concentrations of BAY 38–7268 (free base of BAY 38–9456 vardenafil hydrochloride) and its major active metabolite BAY 44–5576 for population-pharmacokinetics at baseline (at screening) and at certain time intervals after administration of the test drug. Plasma concentrations were measured by using a validated HPLC/MS/MS-assay with limits of quantification of 0.1 µg/L (BAY 38–7268) and 0.5 µg/L (BAY 44–5576), respectively ().