Ocular side effects of levitra ® (vardenafil) - results of a double-blind crossover study in healthy male subjects
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 hydroc...
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| Vydané v: | Drug design, development and therapy Ročník 13; s. 37 - 43 |
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| Médium: | Journal Article |
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New Zealand
Dove Medical Press Limited
01.01.2019
Taylor & Francis Ltd Dove Medical Press |
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| ISSN: | 1177-8881, 1177-8881 |
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| Abstract | 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. 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. |
|---|---|
| AbstractList | 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. 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. Gernot Roessler, Michael Vobig, Peter Walter, Babac AE Mazinani Department of Ophthalmology, RWTH Aachen University, D-52057 Aachen, Germany Purpose: To determine ocular side effects of vardenafil with special regard to color vision and retinal function. Methods: 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. Results: 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. Conclusion: Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects. Keywords: phosophodiesterase-5 inhibitor, retinal function, color vision, electroretinogram, adverse events, placebo-controlled Purpose: To determine ocular side effects of vardenafil with special regard to color vision and retinal function. Methods: 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. Results: 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. Conclusion: Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects. Keywords: phosophodiesterase-5 inhibitor, retinal function, color vision, electroretinogram, adverse events, placebo-controlled To determine ocular side effects of vardenafil with special regard to color vision and retinal function.PURPOSETo 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.METHODSThis 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. 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.RESULTSCompared 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.Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects.CONCLUSIONDespite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects. Purpose: To determine ocular side effects of vardenafil with special regard to color vision and retinal function. Methods: 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. Results: 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. Conclusion: Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects. |
| Audience | Academic |
| Author | Roessler, Gernot Vobig, Michael Walter, Peter Mazinani, Babac AE |
| AuthorAffiliation | Department of Ophthalmology, RWTH Aachen University, D-52057 Aachen, Germany, groessler@ukaachen.de |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30587926$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_3390_molecules28104116 crossref_primary_10_1016_j_exer_2024_109890 crossref_primary_10_1080_14740338_2019_1659244 crossref_primary_10_7759_cureus_76190 crossref_primary_10_1016_j_cbi_2025_111745 crossref_primary_10_1016_j_survophthal_2021_06_004 crossref_primary_10_1016_j_ejmech_2024_116769 crossref_primary_10_1016_j_survophthal_2025_04_003 |
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| Copyright | COPYRIGHT 2019 Dove Medical Press Limited 2019. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 Roessler et al. This work is published and licensed by Dove Medical Press Limited 2019 |
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| Snippet | To determine ocular side effects of vardenafil with special regard to color vision and retinal function.
This was a single center, randomized, double-blind,... Purpose: To determine ocular side effects of vardenafil with special regard to color vision and retinal function. Methods: This was a single center,... To determine ocular side effects of vardenafil with special regard to color vision and retinal function.PURPOSETo determine ocular side effects of vardenafil... Gernot Roessler, Michael Vobig, Peter Walter, Babac AE Mazinani Department of Ophthalmology, RWTH Aachen University, D-52057 Aachen, Germany Purpose: To... |
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| SubjectTerms | Acuity Administration, Oral Adolescent Adult BASIC (programming language) Clinical Trial Report Color Color vision Color Vision - drug effects Comparative analysis Cross-Over Studies Diabetic retinopathy Double-Blind Method Double-blind studies Drug dosages Electrocardiography Electroretinography Erectile dysfunction Errors Germany Humans Latency Male Middle Aged ocular side effects Ophthalmology Patient compliance PDE-5-inhibitors Phosphodiesterase 5 Inhibitors - administration & dosage Phosphodiesterase 5 Inhibitors - adverse effects Retina Retina - drug effects Retina - physiopathology retinal function Side effects Tablets Time Factors Vardenafil Dihydrochloride - administration & dosage Vardenafil Dihydrochloride - adverse effects Visual acuity Visual field Visual fields Young Adult |
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| Title | Ocular side effects of levitra ® (vardenafil) - results of a double-blind crossover study in healthy male subjects |
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