[Safety and ocular hypotensive effect of a new prostaglandin analogue, S-1033, in normal volunteers].
We conducted a prospective, placebo-controlled, double-masked study to investigate the ocular hypotensive effect and safety of a new prostaglandin analogue, S-1033, in healthy human volunteers. In a single-dose, dose-finding study, where 0.1%, 0.2%, 0.3%, or 0.4% of S-1033 and the vehicle ophthalmic solution was instilled in each one eye of six adult male volunteers and vehicle solution alone in the fellow eye, 0.3% solution showed a significant ocular hypotensive effect at 1, 2, and 8 hours following the instillation and 0.4% solution showed a similar effect at 4 hours after the instillation. The following multiple-dose study, where 0.3% S-1033 solution was instilled twice daily for 8 days in one eye of six volunteers and the vehicle in the follow eye, revealed a significant, continuous intraocular pressure (IOP) reduction. Mild, transient conjunctival hyperemia and slight ocular discomfort developed in some cases, but they were minor. These results indicate that S-1033 has a significant ocular hypotensive effect without substantial adverse effects and the new compound seems to deserve further investigation as a possible anti-glaucoma medication.
Ando
Y
Y
Department of Ophthalmology, Gifu University School of Medicine, Japan.
Matsunami
C
C
Yamamoto
T
T
Kitazawa
Y
Y
D003864:Depression, Chemical; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011453:Prostaglandins / Q000494:pharmacology*
D011453:Prostaglandins; C091523:S 1033