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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 healthy subjects there is little evidence

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Subjects must have given 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 prescription free levitra 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. inhibitors in patients with preexisting ocular pathologies.

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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 ). In comparison to screening ERG with b-wave amplitude of 225±91 µV (2.4 cds/m2), in ERG after 1 hour 20 minutes with active treatment b-wave amplitude was reduced by 15% compared to a reduction of 10% observed with placebo. While there was no relevant difference in b-wave amplitude between the treatment groups after 6 hours 20 minutes, there were again differences between active and placebo after 24 hours (). Compared to a baseline value of 92±41 µV (5 cds/m2), b-wave amplitude was reduced by 27% after 1 hour 20 minutes with active treatment while placebo group showed a reduction of 12%. A less prominent amplitude reduction was still present after 6 hours 20 minutes with active treatment. In our study, visual acuity, refraction, intraocular

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pressure, Humphrey 30-2 visual field test, Amsler grid

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The findings correlated with BAY 38–7268 and its active metabolite’s plasma concentrations. There were no differences after 24 hours between active and placebo. The data indicate a mild and transient impairment of color discrimination particularly in representing color vision of blue/green and purple and go along with the results of investigations performed on ocular side effects of sildenafil revealing similar color vision alterations which resolve within 24 hours in correlation with plasma concentrations of the drug.Citation9,Citation11,Citation18 Moreover, ERG measurements showed reductions of the b-wave amplitude with no relevant effects on a-wave amplitude which predominantly recovered after 24 hours. There were no relevant differences between active and placebo in regard to ERG latency at any time up to 24 hours following drug administration. Studies on retinal function after sildenafil administration show a complete recovery of all ERG parameters within 24 hours.Citation9,Citation13 However, as we found a mild reduction of the b-wave amplitude even 24 hours after ingestion of vardenafil our study design could not deliver data on detecting a more precise point in time for complete recovery. field test, slit-lamp, and funduscopy did not reveal

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the two treatment groups.