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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.

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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. 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.

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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. 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. Twenty-four hours after administration there was no significant alteration of total error score or of any error line. 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.

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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. 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. The trial was registered at the District Council Cologne, Germany under the registration number BAY 38-9456 / 10197.

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Following dark adaptation of 30 minutes ERGs were recorded according to single flash stimulation with constant luminance stimulus (cds/m2) of 2.4 cds/m2 (no background illumination) and 5.0 cds/m2 (additional background illumination of 20 cd/m2). Concentration measurements of BAY 38–7268 and BAY 44–5576 in plasma indicated subject compliance. Moreover, urine probes were taken at baseline to detect possible drug abuse (opiates, amphetamines, barbiturates, cannabis, benzodiazepines, cocaine-metabolites) which would have led to exclusion of the subject. 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.

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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. Adverse events were more common in subjects receiving active BAY 38–9456 (vardenafil hydrochloride) when compared to those receiving placebo. The most frequently reported adverse event in each treatment group was “headache”. 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 ().

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The intensity of all adverse events was reported as “mild” or “moderate” and the relationship to study drug was “possible” in all cases. All adverse events had resolved by the end of the study while there was no evidence for a serious adverse event at any time (). The color discrimination error score of the Farnsworth– Munsell test was the primary variable for the assessment of the visual function. The most pronounced differences between the two treatment groups were observed for total error score 1 and 6 hours after drug administration, and for error score lines 3, and 4 one hour after drug administration, indicating an impairment of color discrimination particularly in representing color vision of blue/green and purple. Minor differences were still present after 6 hours affecting error score lines 1, 3, and 4.

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There were no differences after 24 hours between active and placebo ( and ). 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 ().

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Monitoring of safety and tolerability of treatment included subjective parameters like well-being and AEs communicated by the subjects and classified by investigators according to their severity and if AEs were non-serious or serious. Objective parameters were monitored by measurement of heart rate, blood pressure and recording of standard electrocardiogram (ECG). Moreover, blood samples were examined in regard to possible alterations of hematological and clinical chemistry parameters. Each of the two treatment periods consisted of one profile day and at 24-hours follow-up examination. Subjects were discharged from the study ward about 1–2 hours after the last examination on days 0 and 1, provided there were no medical objections. There was a wash-out phase of at least one week between each of the two periods.

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For each subject the study ended with the final examination approximately 1–2 weeks after the second study period. The total duration of the study was four months. Eye-specific inclusion/exclusion criteria were examined for both eyes. However, only one eye was included for study use.

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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. 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 .

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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 (). Monitoring of safety and tolerability of treatment included subjective parameters like well-being and AEs communicated by the subjects and classified by investigators according to their severity and if AEs were non-serious or serious. Objective parameters were monitored by measurement of heart rate, blood pressure and recording of standard electrocardiogram (ECG). The study was conducted in accordance with the Declaration of Helsinki (1964) in the revised version of 1996 (Somerset West) and 2000 (Edinburgh), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP Guideline (Note for Guidance on Good Clinical Practice) and the German drug law [Arzneimittelgesetz].

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Moreover, blood samples were examined in regard to possible alterations of hematological and clinical chemistry parameters. Each of the two treatment periods consisted of one profile day and at 24-hours follow-up examination. Subjects were discharged from the study ward about 1–2 hours after the last examination on days 0 and 1, provided there were no medical objections. There was a wash-out phase of at least one week between each of the two periods. For each subject the study ended with the final examination approximately 1–2 weeks after the second study period.

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The total duration of the study was four months. Eye-specific inclusion/exclusion criteria were examined for both eyes. However, only one eye was included for study use. The study was conducted in accordance with the Declaration of Helsinki (1964) in the revised version of 1996 (Somerset West) and 2000 (Edinburgh), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP Guideline (Note for Guidance on Good Clinical Practice) and the German drug law [Arzneimittelgesetz]. The study protocol was approved by the Ethics Committee of the Medical Faculty, University of Cologne. The study protocol was approved by the Ethics Committee of the Medical Faculty, University of Cologne. Subjects must have given levitra no prescription online their written informed consent to participate in the study after receiving adequate previous information. As test drug vardenafil (free base of BAY 38–9456) was administered orally at dosage of two tablets of 20 mg or corresponding placebo. Medication was given once on day 0 (0d 00) of each study period () and in accordance with the randomization list. In order to detect potential ophthalmological changes, BAY 38–9456 (vardenafil hydrochloride) 40 mg was chosen, which was double the expected highest prescribed future dose.

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A 40 mg dose had previously been found safe in a number of Phase I studies. The amount of dose in the tablet refers to the free base BAY 38–7268 (vardenafil).

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On study days, eye examinations were done in the following order (time needed per examination in brackets; reference is also provided in study flowchart, ): Humphrey 30-2 visual field test (20 minutes) Humphrey 30-2 visual field test (20 minutes) Administration of eye drops for mydriasis and waiting period (30 minutes) Administration of eye drops for mydriasis and waiting period (30 minutes) The color discrimination error score of this test was the primary variable for the assessment of visual function. Total error score was calculated based on the test results for the individual caps.

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In addition, partial scores (error lines 1–4) were calculated for each of the four boxes of the Farnsworth–Munsell 100 test. According to published data square root of error scores were used to reach a better approximation of the normal distribution.Citation16 Scotopic and photopic ERG measurements were performed according to International Society for Clinical Electrophysiology of Vision (ISCEV) standards.Citation17 ERGs were recorded by Amplaid MK15 evoked potential system (Amplaid USA Inc., Rolling Meadows, IL, USA) connected to corneal jet electrodes.

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Subjects must have given levitra no prescription online their written informed consent to participate in the study after receiving adequate previous information. As test drug vardenafil (free base of BAY 38–9456) was administered orally at dosage of two tablets of 20 mg or corresponding placebo. Medication was given once on day 0 (0d 00) of each study period () and in accordance with the randomization list. In order to detect potential ophthalmological changes, BAY 38–9456 (vardenafil hydrochloride) 40 mg was chosen, which was double the expected highest prescribed future dose. A 40 mg dose had previously been found safe in a number of Phase I studies.

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The amount of dose in the tablet refers to the free base BAY 38–7268 (vardenafil). On study days, eye examinations were done in the following order (time needed per examination in brackets; reference is also provided in study flowchart, ): Humphrey 30-2 visual field test (20 minutes) Humphrey 30-2 visual field test (20 minutes) Administration of eye drops for mydriasis and waiting period (30 minutes) Administration of eye drops for mydriasis and waiting period (30 minutes) The color discrimination error score of this test was the primary variable for the assessment of visual function. Total error score was calculated based on the test results for the individual caps. In addition, partial scores (error lines 1–4) were calculated for each of the four boxes of the Farnsworth–Munsell 100 test. According to published data square root of error scores were used to reach a better approximation of the normal distribution.Citation16 Scotopic and photopic ERG measurements were performed according to International Society for Clinical Electrophysiology of Vision (ISCEV) standards.Citation17 ERGs were recorded by Amplaid MK15 evoked potential system (Amplaid USA Inc., Rolling Meadows, IL, USA) connected to corneal jet electrodes. Following dark adaptation of 30 minutes ERGs were recorded according to single flash stimulation with constant luminance stimulus (cds/m2) of 2.4 cds/m2 (no background illumination) and 5.0 cds/m2 (additional background illumination of 20 cd/m2). Concentration measurements of BAY 38–7268 and BAY 44–5576 in plasma indicated subject compliance. Moreover, urine probes were taken at baseline to detect possible drug abuse (opiates, amphetamines, barbiturates, cannabis, benzodiazepines, cocaine-metabolites) which would have led to exclusion of the subject. 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.

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Adverse events were more common in subjects receiving active BAY 38–9456 (vardenafil hydrochloride) when compared to those receiving placebo. The most frequently reported adverse event in each treatment group was “headache”. The intensity of all adverse events was reported as “mild” or “moderate” and the relationship to study drug was “possible” in all cases. All adverse events had resolved by the end of the study while there was no evidence for a serious adverse event at any time (). The color discrimination error score of the Farnsworth– Munsell test was the primary variable for the assessment of the visual function. The most pronounced differences between the two treatment groups were observed for total error score 1 and 6 hours after drug administration, and for error score lines 3, and 4 one hour after drug administration, indicating an impairment of color discrimination particularly in representing color vision of blue/green and purple. Minor differences were still present after 6 hours affecting error score lines 1, 3, and 4. There were no differences after 24 hours between active and placebo ( and ).