Accepted for publication 7 November 2018 Published 18 December 2018 Volume 20 Pages 37—43 DOI https://doi.org/10.2147/DDDT. S186633 Checked for plagiarism Yes Review by Single-blind Peer reviewers approved by Dr Colin Mak Peer reviewer comments 3 Editor who approved publication: Dr Anastasios Lymperopoulos 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. A comprehensive review of the safety and effectiveness of this drug. If the drug is not a Do Not Use product, information on adverse effects, drug interactions and how to use the medication are included.
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