[Ocular effects of topical instillation of UF-021 ophthalmic solution in healthy volunteers].
Phase I studies, as divided into two stages, were conducted in healthy volunteers with the ophthalmic solution of UF-021, a novel prostaglandin metabolite-related compound, that was reported to exhibit potent intraocular pressure (IOP)-reducing activity in various species of animals. In the first stage, the vehicle as well as UF-021 ophthalmic solutions at concentration of 0.03%, 0.06% and 0.09% were applied topically to the eyes of 8 healthy volunteers to determine their respective effects through observations on the IOP, and local ocular and systemic side effects. In the second stage, 2 dosages of UF-021 ophthalmic solution, 0.06% and 0.12%, were applied topically to 11 healthy volunteers to investigate the IOP-reducing activities and local ocular side effects. The results revealed that ophthalmic solutions of UF-021 at concentrations ranging from 0.03% to 0.12% reduced IOP in a dose-dependent manner with neither systemic nor local ocular controversial side effects at those dosage levels. In summary, UF-021 ophthalmic solutions, when administered to healthy volunteers through single instillation, reduced IOP significantly without causing any side effects.
Takase
M
M
Department of Ophthalmology, Japan Self Defense Force Central Hospital, Setagaya-ku.
Murao
M
M
Koyano
S
S
Okita
M
M
Ueno
R
R
D000287:Administration, Topical; D000328:Adult; D003864:Depression, Chemical; D015237:Dinoprost / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D005123:Eye / Q000187:drug effects*; D006801:Humans; D007322:Instillation, Drug; D007429:Intraocular Pressure / Q000187:drug effects; D009883:Ophthalmic Solutions
D009883:Ophthalmic Solutions; C072630:isopropyl unoprostone; D015237:Dinoprost