Ocular side effects of levitra ® (vardenafil) - results of a double-blind crossover study in healthy male subjects

• Published in: Drug design, development and therapy Vol. 13; pp. 37 - 43
• Main Authors: Roessler, Gernot, Vobig, Michael, Walter, Peter, Mazinani, Babac AE
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2019; Taylor & Francis Ltd; Dove Medical Press
• Subjects: 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; Germany; electroretinogram; phosophodiesterase-5 inhibitor; placebo-controlled; adverse events; color vision; retinal function
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S186633

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.