UMIN ID: UMIN000000518
Registered date:13/11/2006
Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution in healthy adult male volunteers. -ocular blood flow measurements as efficacy endpoints-
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Glaucoma |
| Date of first enrollment | 2006/03/01 |
| Target sample size | 12 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 0.0015% DE-085 (Tafluprost) ophthalmic solution One drop at a time, single administration in the right eye 0.01% bunazosin hydrochloride ophthalmic solution One drop at a time, single administration in the right eye |
Outcome(s)
| Primary Outcome | (1) Peripapillary retinal and neuroretinal rim hemodynamics (2) Peripapillary retinal artery hemodynamics |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 35years-old |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1) Any clinically abnormal findings at screening examinations. |
Related Information
| Primary Sponsor | Santen Pharmaceutical Co., Ltd. |
|---|---|
| Secondary Sponsor | Medical Corporation Kojinkai Kita13-jo naika Clinic |
| Source(s) of Monetary Support | Santen Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| clinical@santen.co.jp | |
| Affiliation | Santen Pharmaceutical Co., Ltd. Clinical Development Group |
| scientific contact | |
| Name | Akitoshi Yoshida |
| Address | 1-1-1, Higashi 2-jou, Midorigaoka, Asahikawa 075-8510, Japan Japan |
| Telephone | |
| Affiliation | Asahikawa Medical College Ophthalmology |