UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000518 |
|---|---|
| Receipt number | R000000625 |
| Scientific Title | Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution in healthy adult male volunteers. -ocular blood flow measurements as efficacy endpoints- |
| Date of disclosure of the study information | 2006/11/13 |
| Last modified on | 2006/11/09 12:28:14 |
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Basic information
Public title
Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution in healthy adult male volunteers. -ocular blood flow measurements as efficacy endpoints-
Acronym
Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution.
Scientific Title
Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution in healthy adult male volunteers. -ocular blood flow measurements as efficacy endpoints-
Scientific Title:Acronym
Clinicalpharmacological study of 0.0015% DE-085 (tafluprost) ophthalmic solution.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted to investigate the effect of 0.0015% DE-085 (Tafluprost) ophthalmic solution on ocular hemodynamics. Healthy adult male volunteers were enrolled in this study, and 0.01% bunazosin hydrochloride ophthalmic solution (Detantol 0.01% ophthalmic solution) was used as a control drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
(1) Peripapillary retinal and neuroretinal rim hemodynamics
(2) Peripapillary retinal artery hemodynamics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
0.0015% DE-085 (Tafluprost) ophthalmic solution
One drop at a time, single administration in the right eye
Interventions/Control_2
0.01% bunazosin hydrochloride ophthalmic solution
One drop at a time, single administration in the right eye
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Age of 20 to 35 years old;
2) Gender: male;
3) Subject who can complete the prescribed course and comply with appropriate instructions.
Key exclusion criteria
1) Any clinically abnormal findings at screening examinations.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitoshi Yoshida |
Organization
Asahikawa Medical College
Division name
Ophthalmology
Zip code
Address
1-1-1, Higashi 2-jou, Midorigaoka, Asahikawa 075-8510, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Clinical Development Group
Zip code
Address
TEL
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Kojinkai Kita13-jo naika Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
It can be suggested that 0.0015% DE-085 ophthalmic solution and 0.01% bunazosin hydrochloride ophthalmic solution (one drop at a time, single administration) increase the blood flow in human retinal and retinal artery.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 09 | Day |
Last modified on
| 2006 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000625
