UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004818
Receipt number R000005681
Scientific Title Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects
Date of disclosure of the study information 2012/04/01
Last modified on 2013/02/05 08:26:15

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Basic information

Public title

Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects

Acronym

Tafluprost and ocular blood flow

Scientific Title

Quantitative analysis of effect of topical tafluprost on ocular blood flow in normal subjects

Scientific Title:Acronym

Tafluprost and ocular blood flow

Region

Japan


Condition

Condition

normal subjects

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effect of topical tafluprost on ocular blood flow in normal subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quantitative index of blood velocity in ocular tissues obtained with laser speckle method

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Unilateral eyes with topical tafluprost instillation (unilateral)

Interventions/Control_2

Contralateral eyes without drug instillation

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal subjects not falling under the exclusion criteria

Key exclusion criteria

History or presence of systemic diseases that could affect general circulation including hyper tension, cardiac diseases, diabetes mellitus, or arterial sclerosis.
History or presence of ocular diseases that could affect measurement of ocular blood flow including cataract, diabetic retinopathy/maculopathy, age-related macular degeneration, glaucoma and optic nerve or retinal abnormality.
History of intraocular or refractive surgery.
Habitual smoking, pregnancy, or lactation.
Those judged to be inappropriate for the participation by the responsible researchers.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiro Mayama

Organization

University of Tokyo Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

7-3-1, hongo, bunkyo-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

University of Tokyo Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

7-3-1, hongo, bunkyo-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Ophthalmology,University of Tokyo Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2012 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2011 Year 01 Month 16 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2012 Year 09 Month 01 Day

Date analysis concluded

2012 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 04 Day

Last modified on

2013 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005681


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name