T. Yajima et al., No clinically important effects on intraocular pressure after short-term administration of sildenafil citrate (Viagra), AM J OPHTH, 129(5), 2000, pp. 675-676
PURPOSE: To assess the short-term effects of sildenafil citrate on intraocu
lar pressure in healthy male volunteers and participants in clinical trials
.
METHODS: Intraocular pressure and pupil diameter were measured in two place
bo-controlled studies. Oral doses of sildenafil citrate (VIAGRA; Pfizer Inc
, New York, New York) ranged from 10 mg to 150 mg,
RESULTS: No major changes in intraocular pressure or pupillometry were dete
cted at any time (1.0-24 hours) after administration of sildenafil. Additio
nally, of 36 subjects with a medical history of increased intraocular press
ure in the sildenafil safety database, none were reported to have a clinica
lly significant increase of their intraocular pressure. During clinical tri
als, two glaucoma cases were listed as serious adverse events, but were not
considered treatment related.
CONCLUSION: No clinical abnormalities were observed in intraocular pressure
or pupil diameter in subjects receiving sildenafil. Currently, no evidence
suggests that longterm treatment with sildenafil has an effect on intraocu
lar pressure or is associated with the development or worsening of glaucoma
. (C) 2000 by Elsevier Science Inc. All rights reserved.